POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM

Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling

OPTICAL SENSORS, INC.

The following data is part of a premarket notification filed by Optical Sensors, Inc. with the FDA for Point-of-care Arterial Blood Gas Monitoring System.

Pre-market Notification Details

Device IDK951094
510k NumberK951094
Device Name:POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM
ClassificationAnalyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Applicant OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE A Eden Prairie,  MN  55344
ContactGary Syring
CorrespondentGary Syring
OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE A Eden Prairie,  MN  55344
Product CodeCCC  
CFR Regulation Number868.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-09
Decision Date1996-01-16

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