UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-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 Umbilical Artery Oxygen Probe Model Uap-100.

Pre-market Notification Details

Device IDK872896
510k NumberK872896
Device Name:UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-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 Received1987-07-23
Decision Date1988-02-12

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