510(k) Final Decisions Rendered since October 01, 2009

510(k) Final Decisions Rendered since October 01, 2009 U.S. Food and Drug Administration - Center for Devices and Radiological Health http://www.fda.gov/cdrh/510khome.html en-us Sun, 08 Nov 2009 12:28:20 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: K092729 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31395 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K092111 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31202 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K092471 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31330 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K092037 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31168 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K090712 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30401 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K091679 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30995 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K090919 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30545 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K090568 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30311 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K092676 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31384 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K091217 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30730 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K091721 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31017 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K091386 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30826 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K092026 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31163 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K092058 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31179 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K092016 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31157 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K092041 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31171 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K092082 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31190 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K091332 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30798 Fri, 02 Oct 2009 04:00:00 GMT 510(k) No: K090841 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30492 Mon, 05 Oct 2009 04:00:00 GMT 510(k) No: K092112 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31203 Tue, 06 Oct 2009 04:00:00 GMT 510(k) No: K090716 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30404 Tue, 06 Oct 2009 04:00:00 GMT 510(k) No: K092197 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31226 Tue, 06 Oct 2009 04:00:00 GMT 510(k) No: K092218 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31235 Tue, 06 Oct 2009 04:00:00 GMT 510(k) No: K091878 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31090 Tue, 06 Oct 2009 04:00:00 GMT 510(k) No: K091907 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31103 Tue, 06 Oct 2009 04:00:00 GMT 510(k) No: K092287 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31257 Tue, 06 Oct 2009 04:00:00 GMT 510(k) No: K092070 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31183 Tue, 06 Oct 2009 04:00:00 GMT 510(k) No: K091918 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31111 Wed, 07 Oct 2009 04:00:00 GMT 510(k) No: K091613 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30959 Wed, 07 Oct 2009 04:00:00 GMT 510(k) No: K092085 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31192 Wed, 07 Oct 2009 04:00:00 GMT 510(k) No: K093018 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31434 Wed, 07 Oct 2009 04:00:00 GMT 510(k) No: K090724 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30411 Wed, 07 Oct 2009 04:00:00 GMT 510(k) No: K092516 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31341 Wed, 07 Oct 2009 04:00:00 GMT 510(k) No: K092949 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31427 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092509 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31339 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092834 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31410 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092431 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31321 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K090051 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29927 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K091540 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30921 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092253 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31249 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092804 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31405 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092014 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31155 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K090361 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30167 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092204 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31230 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092575 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31357 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092863 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31413 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092763 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31401 Thu, 08 Oct 2009 04:00:00 GMT 510(k) No: K092225 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31239 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092182 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31222 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K090653 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30358 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K091758 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31034 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K091440 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30864 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092212 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31233 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K091767 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31039 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K090991 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30589 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092770 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31402 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092297 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31263 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092513 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31340 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092650 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31379 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K083552 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29608 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K090563 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30306 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K091787 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31048 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092432 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31322 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092806 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31406 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K091584 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30942 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092566 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31354 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K091803 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31057 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K090190 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30039 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K091623 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30963 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092939 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31425 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K090705 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30396 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092747 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31397 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092105 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31199 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092049 - Decision: SUBSTANTIALLY EQUIVALENT - KIT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31174 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092962 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31430 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K091216 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30729 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K090650 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30356 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092810 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31407 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K091574 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30938 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092757 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31399 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092948 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31426 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092103 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31198 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K092109 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31201 Fri, 09 Oct 2009 04:00:00 GMT 510(k) No: K090017 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29906 Tue, 13 Oct 2009 04:00:00 GMT 510(k) No: K091709 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31014 Tue, 13 Oct 2009 04:00:00 GMT 510(k) No: K090459 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30233 Tue, 13 Oct 2009 04:00:00 GMT 510(k) No: K092389 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31304 Tue, 13 Oct 2009 04:00:00 GMT 510(k) No: K091369 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30815 Wed, 14 Oct 2009 04:00:00 GMT 510(k) No: K090472 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30243 Wed, 14 Oct 2009 04:00:00 GMT 510(k) No: K091703 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31011 Wed, 14 Oct 2009 04:00:00 GMT 510(k) No: K092408 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31310 Wed, 14 Oct 2009 04:00:00 GMT 510(k) No: K092156 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31216 Wed, 14 Oct 2009 04:00:00 GMT 510(k) No: K091420 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30850 Wed, 14 Oct 2009 04:00:00 GMT 510(k) No: K091091 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30645 Wed, 14 Oct 2009 04:00:00 GMT 510(k) No: K091140 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30678 Wed, 14 Oct 2009 04:00:00 GMT 510(k) No: K092035 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31167 Thu, 15 Oct 2009 04:00:00 GMT 510(k) No: K091471 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30881 Thu, 15 Oct 2009 04:00:00 GMT 510(k) No: K092336 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31282 Thu, 15 Oct 2009 04:00:00 GMT 510(k) No: K091458 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30874 Thu, 15 Oct 2009 04:00:00 GMT 510(k) No: K092177 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31220 Thu, 15 Oct 2009 04:00:00 GMT 510(k) No: K090006 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29898 Thu, 15 Oct 2009 04:00:00 GMT 510(k) No: K092838 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31411 Thu, 15 Oct 2009 04:00:00 GMT 510(k) No: K090008 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29900 Thu, 15 Oct 2009 04:00:00 GMT 510(k) No: K092691 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31388 Thu, 15 Oct 2009 04:00:00 GMT 510(k) No: K091624 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30964 Thu, 15 Oct 2009 04:00:00 GMT 510(k) No: K092337 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31283 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K091846 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31075 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K092913 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31422 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K091833 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31070 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K092570 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31355 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K091065 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30632 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K091780 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31044 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K091781 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31045 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K091848 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31076 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K092039 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31170 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K083260 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29389 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K092876 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31416 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K081265 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=27813 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K092879 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31417 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K092280 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31251 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K091516 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30909 Fri, 16 Oct 2009 04:00:00 GMT 510(k) No: K083626 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29667 Mon, 19 Oct 2009 04:00:00 GMT 510(k) No: K090487 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30256 Mon, 19 Oct 2009 04:00:00 GMT 510(k) No: K092898 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31421 Mon, 19 Oct 2009 04:00:00 GMT 510(k) No: K090474 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30245 Mon, 19 Oct 2009 04:00:00 GMT 510(k) No: K092034 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31166 Mon, 19 Oct 2009 04:00:00 GMT 510(k) No: K092895 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31420 Mon, 19 Oct 2009 04:00:00 GMT 510(k) No: K091777 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31042 Tue, 20 Oct 2009 04:00:00 GMT 510(k) No: K092289 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31258 Tue, 20 Oct 2009 04:00:00 GMT 510(k) No: K091542 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30922 Tue, 20 Oct 2009 04:00:00 GMT 510(k) No: K082891 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29102 Tue, 20 Oct 2009 04:00:00 GMT 510(k) No: K092561 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31351 Tue, 20 Oct 2009 04:00:00 GMT 510(k) No: K090703 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30394 Tue, 20 Oct 2009 04:00:00 GMT 510(k) No: K083163 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29318 Tue, 20 Oct 2009 04:00:00 GMT 510(k) No: K092221 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31236 Tue, 20 Oct 2009 04:00:00 GMT 510(k) No: K091354 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30806 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092824 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31409 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092425 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31319 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092294 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31261 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092296 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31262 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K091414 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30845 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092616 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31366 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092882 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31418 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092887 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31419 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092957 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31428 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K090866 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30510 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092101 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31196 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K082756 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=28995 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K093116 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31437 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092411 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31311 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092283 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31253 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092604 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31363 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092492 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31333 Wed, 21 Oct 2009 04:00:00 GMT 510(k) No: K092301 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31266 Thu, 22 Oct 2009 04:00:00 GMT 510(k) No: K092010 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31151 Thu, 22 Oct 2009 04:00:00 GMT 510(k) No: K092783 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31403 Thu, 22 Oct 2009 04:00:00 GMT 510(k) No: K091499 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30897 Thu, 22 Oct 2009 04:00:00 GMT 510(k) No: K091389 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30828 Thu, 22 Oct 2009 04:00:00 GMT 510(k) No: K090823 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30476 Thu, 22 Oct 2009 04:00:00 GMT 510(k) No: K092630 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31372 Thu, 22 Oct 2009 04:00:00 GMT 510(k) No: K092990 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31432 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K091240 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30744 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K090751 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30430 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K091102 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30653 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K093183 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31440 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K082207 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=28555 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K091305 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30783 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K091871 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31087 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K092418 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31316 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K090897 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30530 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K091100 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30652 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K092456 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31327 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K092443 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31324 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K092961 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31429 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K090641 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30351 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K091191 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30713 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K092919 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31423 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K091606 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30955 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K090542 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30292 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K091935 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31118 Fri, 23 Oct 2009 04:00:00 GMT 510(k) No: K091413 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30844 Mon, 26 Oct 2009 04:00:00 GMT 510(k) No: K091000 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30596 Mon, 26 Oct 2009 04:00:00 GMT 510(k) No: K092544 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31347 Mon, 26 Oct 2009 04:00:00 GMT 510(k) No: K091696 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31006 Mon, 26 Oct 2009 04:00:00 GMT 510(k) No: K093058 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31436 Mon, 26 Oct 2009 04:00:00 GMT 510(k) No: K083077 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29247 Mon, 26 Oct 2009 04:00:00 GMT 510(k) No: K092986 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31431 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K091196 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30718 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K092150 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31213 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K092873 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31415 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K090055 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29931 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K092381 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31301 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K092281 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31252 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K091915 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31109 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K092303 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31267 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K091064 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30631 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K091446 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30868 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K091174 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30703 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K090139 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29999 Tue, 27 Oct 2009 04:00:00 GMT 510(k) No: K092926 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31424 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K091284 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30768 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K092245 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31245 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K093002 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31433 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K092292 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31260 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K092011 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31152 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K091433 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30859 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K091984 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31139 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K082584 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=28855 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K091726 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31019 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K091566 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30936 Wed, 28 Oct 2009 04:00:00 GMT 510(k) No: K092353 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31287 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K092355 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31288 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K091290 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30774 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K093023 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31435 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K092361 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31291 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K090689 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30383 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K093251 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31443 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K090639 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30350 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K091916 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31110 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K083080 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29250 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K091761 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31037 Thu, 29 Oct 2009 04:00:00 GMT 510(k) No: K083133 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29292 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092318 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31275 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K091913 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31108 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K093300 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31446 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092205 - Decision: SUBSTANTIALLY EQUIVALENT - KIT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31231 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K091736 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31024 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092547 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31348 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K093221 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31441 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K093234 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31442 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092623 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31368 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092717 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31393 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092536 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31344 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K091115 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30662 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092581 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31360 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092309 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31270 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K091512 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30906 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K090539 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30290 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092585 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31361 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092251 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31248 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K090887 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30524 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K091441 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30865 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092342 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31284 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K092403 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31307 Fri, 30 Oct 2009 04:00:00 GMT 510(k) No: K082534 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=28818 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K091653 - Decision: SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30982 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K091531 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30916 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K092362 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31292 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K092359 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31290 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K092317 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31274 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K091607 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30956 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K091643 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30977 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K091743 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31029 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K091192 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30714 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K092167 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31219 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K092378 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31300 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K092790 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31404 Mon, 02 Nov 2009 05:00:00 GMT 510(k) No: K092364 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31293 Tue, 03 Nov 2009 05:00:00 GMT 510(k) No: K092446 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31325 Tue, 03 Nov 2009 05:00:00 GMT 510(k) No: K091625 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30965 Tue, 03 Nov 2009 05:00:00 GMT 510(k) No: K091927 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31116 Tue, 03 Nov 2009 05:00:00 GMT 510(k) No: K092320 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31277 Tue, 03 Nov 2009 05:00:00 GMT 510(k) No: K092386 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31303 Tue, 03 Nov 2009 05:00:00 GMT 510(k) No: K092368 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31295 Tue, 03 Nov 2009 05:00:00 GMT 510(k) No: K092822 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31408 Tue, 03 Nov 2009 05:00:00 GMT 510(k) No: K092377 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31299 Tue, 03 Nov 2009 05:00:00 GMT 510(k) No: K092313 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31272 Wed, 04 Nov 2009 05:00:00 GMT 510(k) No: K092384 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31302 Wed, 04 Nov 2009 05:00:00 GMT 510(k) No: K092072 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31184 Wed, 04 Nov 2009 05:00:00 GMT 510(k) No: K092406 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31309 Wed, 04 Nov 2009 05:00:00 GMT 510(k) No: K092657 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31381 Wed, 04 Nov 2009 05:00:00 GMT 510(k) No: K093170 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31439 Wed, 04 Nov 2009 05:00:00 GMT 510(k) No: K093130 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31438 Wed, 04 Nov 2009 05:00:00 GMT 510(k) No: K092490 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31332 Wed, 04 Nov 2009 05:00:00 GMT 510(k) No: K093270 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31444 Wed, 04 Nov 2009 05:00:00 GMT 510(k) No: K093276 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31445 Wed, 04 Nov 2009 05:00:00 GMT 510(k) No: K092563 - Decision: SUBSTANTIALLY EQUIVALENT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=31353 Wed, 04 Nov 2009 05:00:00 GMT