UMBILICAL ARTERY OXYGEN SENSOR

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

OHMEDA MEDICAL

The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Umbilical Artery Oxygen Sensor.

Pre-market Notification Details

Device IDK875225
510k NumberK875225
Device Name:UMBILICAL ARTERY OXYGEN SENSOR
ClassificationAnalyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Applicant OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa,  FL  33702
ContactJill Phillips
CorrespondentJill Phillips
OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa,  FL  33702
Product CodeCCE  
CFR Regulation Number868.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-22
Decision Date1988-03-04

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