510(k) Final Decisions Rendered since April 01, 2013

510(k) Final Decisions Rendered since April 01, 2013 U.S. Food and Drug Administration - Center for Devices and Radiological Health http://www.fda.gov/cdrh/510khome.html en-us Sat, 18 May 2013 10:41:35 GMT webo@cdrh.fda.gov http://www.fda.gov/graphics/mastheadart/centers/fda_mast_01.gif U.S. Food and Drug Administration - Center for Devices and Radiological Health http://www.fda.gov/cdrh/ Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use. 116 70 510(k) No: K123943 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41775 Tue, 02 Apr 2013 04:00:00 GMT 510(k) No: K130576 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41978 Tue, 02 Apr 2013 04:00:00 GMT 510(k) No: K123820 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41710 Tue, 02 Apr 2013 04:00:00 GMT 510(k) No: K130453 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41959 Tue, 02 Apr 2013 04:00:00 GMT 510(k) No: K130470 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41964 Tue, 02 Apr 2013 04:00:00 GMT 510(k) No: K130361 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41940 Tue, 02 Apr 2013 04:00:00 GMT 510(k) No: K123860 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41730 Tue, 02 Apr 2013 04:00:00 GMT 510(k) No: K123541 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41555 Tue, 02 Apr 2013 04:00:00 GMT 510(k) No: K124042 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41822 Tue, 02 Apr 2013 04:00:00 GMT 510(k) No: K121916 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40533 Tue, 02 Apr 2013 04:00:00 GMT 510(k) No: K130194 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41889 Wed, 03 Apr 2013 04:00:00 GMT 510(k) No: K130023 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41836 Wed, 03 Apr 2013 04:00:00 GMT 510(k) No: K123829 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41714 Wed, 03 Apr 2013 04:00:00 GMT 510(k) No: K130423 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41953 Wed, 03 Apr 2013 04:00:00 GMT 510(k) No: K130659 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41995 Wed, 03 Apr 2013 04:00:00 GMT 510(k) No: K123942 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41774 Wed, 03 Apr 2013 04:00:00 GMT 510(k) No: K130285 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41921 Wed, 03 Apr 2013 04:00:00 GMT 510(k) No: K121951 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40559 Thu, 04 Apr 2013 04:00:00 GMT 510(k) No: K123263 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41377 Thu, 04 Apr 2013 04:00:00 GMT 510(k) No: K123808 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41702 Thu, 04 Apr 2013 04:00:00 GMT 510(k) No: K130765 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42012 Thu, 04 Apr 2013 04:00:00 GMT 510(k) No: K122194 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40723 Thu, 04 Apr 2013 04:00:00 GMT 510(k) No: K123507 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41535 Thu, 04 Apr 2013 04:00:00 GMT 510(k) No: K122688 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41039 Thu, 04 Apr 2013 04:00:00 GMT 510(k) No: K121576 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40283 Thu, 04 Apr 2013 04:00:00 GMT 510(k) No: K130422 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41952 Thu, 04 Apr 2013 04:00:00 GMT 510(k) No: K123732 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41659 Thu, 04 Apr 2013 04:00:00 GMT 510(k) No: K123089 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41275 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123796 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41695 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K124027 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41818 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123241 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41367 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123353 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41437 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130521 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41973 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K122307 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40802 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123961 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41785 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123122 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41296 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130006 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41831 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130744 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42007 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130782 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42015 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130469 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41963 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123806 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41701 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123701 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41645 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130069 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41851 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123429 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41486 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123410 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41473 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130308 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41926 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K122453 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40894 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K122049 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40623 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K121478 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40203 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130400 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41947 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130588 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41979 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123892 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41745 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K122198 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40725 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K123243 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41368 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130237 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41908 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130698 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42001 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K121281 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40047 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130340 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41935 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K130044 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41843 Fri, 05 Apr 2013 04:00:00 GMT 510(k) No: K122966 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41208 Mon, 08 Apr 2013 04:00:00 GMT 510(k) No: K123664 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41624 Mon, 08 Apr 2013 04:00:00 GMT 510(k) No: K123962 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41786 Mon, 08 Apr 2013 04:00:00 GMT 510(k) No: K122112 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40667 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K130571 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41977 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K130321 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41928 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K112996 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=38331 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K130383 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41942 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K123996 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41808 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K130665 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41996 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K130371 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41941 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K123153 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41309 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K123978 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41798 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K123916 - Decision: SUBSTANTIALLY EQUIVALENT - KIT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41758 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K123786 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41692 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K130215 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41898 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K123770 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41681 Tue, 09 Apr 2013 04:00:00 GMT 510(k) No: K123703 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41647 Wed, 10 Apr 2013 04:00:00 GMT 510(k) No: K130637 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41991 Wed, 10 Apr 2013 04:00:00 GMT 510(k) No: K130646 - Decision: SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41993 Wed, 10 Apr 2013 04:00:00 GMT 510(k) No: K122470 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40908 Wed, 10 Apr 2013 04:00:00 GMT 510(k) No: K123784 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41691 Wed, 10 Apr 2013 04:00:00 GMT 510(k) No: K123708 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41651 Wed, 10 Apr 2013 04:00:00 GMT 510(k) No: K122996 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41226 Wed, 10 Apr 2013 04:00:00 GMT 510(k) No: K130291 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41923 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K130465 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41961 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K123700 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41644 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K130711 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42002 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K122239 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40753 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K130120 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41866 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K130306 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41924 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K122069 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40637 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K130056 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41846 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K130121 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41867 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K130813 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42019 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K123339 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41427 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K122505 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40935 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K123393 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41463 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K123461 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41506 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K122455 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40896 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K123777 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41686 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K123293 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41396 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K122812 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41107 Thu, 11 Apr 2013 04:00:00 GMT 510(k) No: K123935 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41769 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K130677 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41999 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K130761 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42009 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K130678 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42000 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K122418 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40869 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K113439 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=38695 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K123430 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41487 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K130884 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42025 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K122537 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40959 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K122464 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40903 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K122223 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40742 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K130803 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42017 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K130119 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41865 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K122994 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41224 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K123387 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41460 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K130929 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42029 Fri, 12 Apr 2013 04:00:00 GMT 510(k) No: K123888 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41742 Mon, 15 Apr 2013 04:00:00 GMT 510(k) No: K122076 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40644 Mon, 15 Apr 2013 04:00:00 GMT 510(k) No: K123909 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41754 Mon, 15 Apr 2013 04:00:00 GMT 510(k) No: K123621 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41602 Mon, 15 Apr 2013 04:00:00 GMT 510(k) No: K130673 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41998 Mon, 15 Apr 2013 04:00:00 GMT 510(k) No: K123853 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41727 Mon, 15 Apr 2013 04:00:00 GMT 510(k) No: K123573 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41573 Mon, 15 Apr 2013 04:00:00 GMT 510(k) No: K122304 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40799 Mon, 15 Apr 2013 04:00:00 GMT 510(k) No: K130114 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41863 Tue, 16 Apr 2013 04:00:00 GMT 510(k) No: K123045 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41256 Tue, 16 Apr 2013 04:00:00 GMT 510(k) No: K130718 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42004 Tue, 16 Apr 2013 04:00:00 GMT 510(k) No: K122823 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41114 Tue, 16 Apr 2013 04:00:00 GMT 510(k) No: K130007 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41832 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K130535 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41974 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K122716 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41055 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K123083 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41273 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K130725 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42005 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K124009 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41816 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K121770 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40429 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K123804 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41699 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K123593 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41584 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K130817 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42020 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K123945 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41776 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K123290 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41394 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K123597 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41587 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K123467 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41511 Wed, 17 Apr 2013 04:00:00 GMT 510(k) No: K130548 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41976 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K130152 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41877 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K121659 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40346 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K130717 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42003 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K123676 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41631 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K130100 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41858 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K130770 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42013 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K130772 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42014 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K123280 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41390 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K123900 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41750 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K122200 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40727 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K122461 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40900 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K130883 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42024 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K124049 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41824 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K122199 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40726 Thu, 18 Apr 2013 04:00:00 GMT 510(k) No: K123716 - Decision: SUBSTANTIALLY EQUIVALENT - KIT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41653 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K130063 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41850 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K121804 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40453 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K130441 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41957 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K130335 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41933 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K130269 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41917 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K130489 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41967 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K122539 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40961 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K122868 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41146 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K122210 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40733 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K130167 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41884 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K130108 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41860 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K123552 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41562 Fri, 19 Apr 2013 04:00:00 GMT 510(k) No: K123483 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41520 Sun, 21 Apr 2013 04:00:00 GMT 510(k) No: K120250 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=39247 Sun, 21 Apr 2013 04:00:00 GMT 510(k) No: K130590 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41980 Mon, 22 Apr 2013 04:00:00 GMT 510(k) No: K122167 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40703 Mon, 22 Apr 2013 04:00:00 GMT 510(k) No: K122381 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40846 Mon, 22 Apr 2013 04:00:00 GMT 510(k) No: K122146 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40691 Mon, 22 Apr 2013 04:00:00 GMT 510(k) No: K123539 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41554 Mon, 22 Apr 2013 04:00:00 GMT 510(k) No: K130318 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41927 Mon, 22 Apr 2013 04:00:00 GMT 510(k) No: K123018 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41241 Tue, 23 Apr 2013 04:00:00 GMT 510(k) No: K130161 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41881 Tue, 23 Apr 2013 04:00:00 GMT 510(k) No: K122485 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40920 Tue, 23 Apr 2013 04:00:00 GMT 510(k) No: K130741 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42006 Tue, 23 Apr 2013 04:00:00 GMT 510(k) No: K130389 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41943 Tue, 23 Apr 2013 04:00:00 GMT 510(k) No: K123307 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41405 Tue, 23 Apr 2013 04:00:00 GMT 510(k) No: K122051 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40625 Tue, 23 Apr 2013 04:00:00 GMT 510(k) No: K130643 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41992 Tue, 23 Apr 2013 04:00:00 GMT 510(k) No: K123973 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41795 Tue, 23 Apr 2013 04:00:00 GMT 510(k) No: K123936 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41770 Wed, 24 Apr 2013 04:00:00 GMT 510(k) No: K123915 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41757 Wed, 24 Apr 2013 04:00:00 GMT 510(k) No: K120989 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=39825 Wed, 24 Apr 2013 04:00:00 GMT 510(k) No: K130896 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42027 Wed, 24 Apr 2013 04:00:00 GMT 510(k) No: K123295 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41397 Wed, 24 Apr 2013 04:00:00 GMT 510(k) No: K122826 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41116 Wed, 24 Apr 2013 04:00:00 GMT 510(k) No: K123658 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41621 Wed, 24 Apr 2013 04:00:00 GMT 510(k) No: K123128 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41298 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K130860 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42021 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K122703 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41049 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K123028 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41248 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K123527 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41546 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K130886 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42026 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K124032 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41820 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K120800 - Decision: SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=39678 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K130445 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41958 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K123282 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41392 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K130030 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41837 Thu, 25 Apr 2013 04:00:00 GMT 510(k) No: K130764 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42011 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K130876 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42023 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K123921 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41762 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K122225 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40743 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K123386 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41459 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K122510 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40939 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K122549 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40968 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K120984 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=39820 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K123990 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41803 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K123271 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41384 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K123755 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41672 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K130201 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41893 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K113781 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=38973 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K122908 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41172 Fri, 26 Apr 2013 04:00:00 GMT 510(k) No: K130762 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42010 Mon, 29 Apr 2013 04:00:00 GMT 510(k) No: K130482 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41965 Mon, 29 Apr 2013 04:00:00 GMT 510(k) No: K130202 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41894 Mon, 29 Apr 2013 04:00:00 GMT 510(k) No: K123421 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41482 Mon, 29 Apr 2013 04:00:00 GMT 510(k) No: K123601 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41589 Mon, 29 Apr 2013 04:00:00 GMT 510(k) No: K123470 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41514 Mon, 29 Apr 2013 04:00:00 GMT 510(k) No: K130222 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41901 Mon, 29 Apr 2013 04:00:00 GMT 510(k) No: K130406 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41949 Mon, 29 Apr 2013 04:00:00 GMT 510(k) No: K123482 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41519 Mon, 29 Apr 2013 04:00:00 GMT 510(k) No: K130957 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42030 Tue, 30 Apr 2013 04:00:00 GMT 510(k) No: K122888 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41159 Tue, 30 Apr 2013 04:00:00 GMT 510(k) No: K120599 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=39519 Tue, 30 Apr 2013 04:00:00 GMT 510(k) No: K130518 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41971 Tue, 30 Apr 2013 04:00:00 GMT 510(k) No: K122767 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41085 Tue, 30 Apr 2013 04:00:00 GMT 510(k) No: K130233 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41905 Tue, 30 Apr 2013 04:00:00 GMT 510(k) No: K122905 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41170 Tue, 30 Apr 2013 04:00:00 GMT 510(k) No: K123941 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41773 Tue, 30 Apr 2013 04:00:00 GMT 510(k) No: K122945 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41197 Tue, 30 Apr 2013 04:00:00 GMT 510(k) No: K122664 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41034 Tue, 30 Apr 2013 04:00:00 GMT 510(k) No: K123636 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41608 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K130968 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42032 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K130216 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41899 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K130169 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41885 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K122595 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40999 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K130434 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41955 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K121613 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40312 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K130626 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41989 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K122347 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40826 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K121401 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40145 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K123550 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41561 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K123932 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41767 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K130899 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42028 Wed, 01 May 2013 04:00:00 GMT 510(k) No: K123953 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41780 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K122368 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40839 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K122525 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40950 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K122196 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40724 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K123971 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41793 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K130039 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41840 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K120532 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=39466 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K130870 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42022 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K130591 - Decision: SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41981 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K130605 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41984 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K130330 - Decision: SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41930 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K130346 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41937 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K130174 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41887 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K130811 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42018 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K123500 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41532 Thu, 02 May 2013 04:00:00 GMT 510(k) No: K130458 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41960 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K122416 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40868 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K122559 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40973 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K130786 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42016 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K120597 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=39517 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K122721 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41059 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K123600 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41588 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K121243 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40016 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K123926 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41765 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K121404 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40148 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K130250 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41912 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K122500 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40931 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K113539 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=38774 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K130632 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41990 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K130147 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41876 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K123159 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41312 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K130594 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41982 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K123486 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41523 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K130334 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41932 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K130084 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41854 Fri, 03 May 2013 04:00:00 GMT 510(k) No: K130963 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42031 Mon, 06 May 2013 04:00:00 GMT 510(k) No: K124016 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41817 Mon, 06 May 2013 04:00:00 GMT 510(k) No: K121702 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40381 Mon, 06 May 2013 04:00:00 GMT 510(k) No: K122404 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40860 Mon, 06 May 2013 04:00:00 GMT 510(k) No: K130624 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41987 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K123368 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41447 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K122707 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41051 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K122741 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41071 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K120590 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=39512 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K122343 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40825 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K131009 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42034 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K123748 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41667 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K130326 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41929 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K122064 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=40633 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K130494 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41969 Tue, 07 May 2013 04:00:00 GMT 510(k) No: K123095 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41280 Wed, 08 May 2013 04:00:00 GMT 510(k) No: K123684 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=41638 Wed, 08 May 2013 04:00:00 GMT 510(k) No: K130990 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=42033 Thu, 09 May 2013 04:00:00 GMT