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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 K060675
Device Name ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS
Applicant
ENVITEC-WISMAR GMBH
S65 W35739 PIPER RD
EAGLE,  WI  53119
Applicant Contact STEPHEN GORSKI
Correspondent
ENVITEC-WISMAR GMBH
S65 W35739 PIPER RD
EAGLE,  WI  53119
Correspondent Contact STEPHEN GORSKI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/14/2006
Decision Date 07/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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