OXYGEN MONITOR OM-100 & OXYGEN PROBE 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 Om-100 & Oxygen Probe Op-100.

Pre-market Notification Details

Device IDK853786
510k NumberK853786
Device Name:OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100
ClassificationAnalyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Applicant AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine,  CA  92714
ContactDonald A Raible
CorrespondentDonald A Raible
AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine,  CA  92714
Product CodeCCE  
CFR Regulation Number868.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-09-10
Decision Date1985-10-16

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