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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, gas, oxygen, gaseous-phase
510(k) Number K122290
Model 1001825, 1001844, 1001830
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 (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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