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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 K931185
Device Name SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE
Applicant
Optical Sensors, Inc.
7615 Golden Triangle Dr.,
Suite C
Eden Prairie,  MN  55344
Applicant Contact GERVAISE WILHELM
Correspondent
Optical Sensors, Inc.
7615 Golden Triangle Dr.,
Suite C
Eden Prairie,  MN  55344
Correspondent Contact GERVAISE WILHELM
Regulation Number868.1150
Classification Product Code
CCC  
Subsequent Product Code
CBZ  
Date Received03/09/1993
Decision Date 10/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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