POINT-OF-CARE BLOOD GAS MONITOR 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 Blood Gas Monitor System.

Pre-market Notification Details

Device IDK961790
510k NumberK961790
Device Name:POINT-OF-CARE BLOOD GAS MONITOR SYSTEM
ClassificationAnalyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Applicant OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE A Eden Prairie,  MN  55344
ContactDenise A Sschottler
CorrespondentDenise A Sschottler
OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE A Eden Prairie,  MN  55344
Product CodeCCC  
Subsequent Product CodeCBZ
Subsequent Product CodeCCE
CFR Regulation Number868.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-09
Decision Date1997-04-09
Summary:summary

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