CLINICAL BLOOD GAS MIXTURES

Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical

NORCO, INC.

The following data is part of a premarket notification filed by Norco, Inc. with the FDA for Clinical Blood Gas Mixtures.

Pre-market Notification Details

Device IDK904163
510k NumberK904163
Device Name:CLINICAL BLOOD GAS MIXTURES
ClassificationTonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical
Applicant NORCO, INC. 1121 WEST AMITY Boise,  ID  83705
ContactLyle Feely
CorrespondentLyle Feely
NORCO, INC. 1121 WEST AMITY Boise,  ID  83705
Product CodeLCH  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-11
Decision Date1990-11-01

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