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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 K953817
Device Name ARISTO MEDICAL MODEL 2101 PATIENT MONITOR
Applicant
ARISTO MEDICAL PRODUCTS, INC.
P.O. BOX 1637
WAUKESHA,  WI  53187 -2345
Applicant Contact STEPHEN H GORSKI
Correspondent
ARISTO MEDICAL PRODUCTS, INC.
P.O. BOX 1637
WAUKESHA,  WI  53187 -2345
Correspondent Contact STEPHEN H GORSKI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/14/1995
Decision Date 11/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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