158 BLOOD GAS ANALYZER

Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for 158 Blood Gas Analyzer.

Pre-market Notification Details

Device IDK820597
510k NumberK820597
Device Name:158 BLOOD GAS ANALYZER
ClassificationElectrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCHL  
CFR Regulation Number862.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-03-04
Decision Date1982-03-26

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