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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K090438
Device Name REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR
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 Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received02/20/2009
Decision Date 07/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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