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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
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 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
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