OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100

Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

AMERICAN BENTLEY

The following data is part of a premarket notification filed by American Bentley with the FDA for Oxygen Monitor No. Om-100, Oxygen Probe No. Op-100.

Pre-market Notification Details

Device IDK860106
510k NumberK860106
Device Name:OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
ClassificationAnalyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Applicant AMERICAN BENTLEY P.O. BOX 19522 Irvine,  CA  92713
ContactDonald A Raible
CorrespondentDonald A Raible
AMERICAN BENTLEY P.O. BOX 19522 Irvine,  CA  92713
Product CodeCCE  
CFR Regulation Number868.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-13
Decision Date1986-02-26

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