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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
S65w35739 Piper Rd.
Egale,  WI  53119
Applicant Contact STEPHEN GORSKI
Correspondent
Envitec-Wismar GmbH
S65w35739 Piper Rd.
Egale,  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
Predetermined Change
Control Plan Authorized		 No
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