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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 K992215
Device Name MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED
Applicant
ENVITEC-WISMAR GMBH
N8259 COTTAGE DR.
FOND DU LAC,  WI  54937
Applicant Contact STEPHEN H GORSKI
Correspondent
ENVITEC-WISMAR GMBH
N8259 COTTAGE DR.
FOND DU LAC,  WI  54937
Correspondent Contact STEPHEN H GORSKI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/01/1999
Decision Date 03/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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