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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 K960251
Device Name COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR
Applicant
Aristo Medical Products, Inc.
407 Pilot Ct., #400-A
Waukesha,  WI  53188
Applicant Contact STEPHEN H GORSKI
Correspondent
Aristo Medical Products, Inc.
407 Pilot Ct., #400-A
Waukesha,  WI  53188
Correspondent Contact STEPHEN H GORSKI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/18/1996
Decision Date 03/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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