• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name analyzer, gas, oxygen, gaseous-phase
510(k) Number K122290
Device Name ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
Original Applicant
ENVITEC-WISMAR GMBH
s65 w35739 piper road
eagle,  WI  53119
Original Contact stephen gorski
Regulation Number868.1720
Classification Product Code
CCL  
Date Received07/30/2012
Decision Date 01/23/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-