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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 K102270
Device Name ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
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  
Date Received08/10/2010
Decision Date 02/22/2011
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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