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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
Device Name ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
Applicant
ENVITEC-WISMAR GMBH
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Applicant Contact STEPHEN GORSKI
Correspondent
ENVITEC-WISMAR GMBH
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Correspondent 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
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