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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K963935
Device Name OLYMPUS CRITICAL CARE MONITORING SYSTEM
Applicant
OPTICAL SENSORS, INC.
7615 GOLDEN TRIANGLE DR.,
SUITE A
EDEN PRAIRIE,  MN  55344
Applicant Contact DENISE SCHOTTLER
Correspondent
OPTICAL SENSORS, INC.
7615 GOLDEN TRIANGLE DR.,
SUITE A
EDEN PRAIRIE,  MN  55344
Correspondent Contact DENISE SCHOTTLER
Regulation Number868.1150
Classification Product Code
CCC  
Date Received10/01/1996
Decision Date 01/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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