BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS

Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling

SHILEY, INC.

The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Biomedical Sensors-shiley Bgm 4000 Intra Blood Gas.

Pre-market Notification Details

Device IDK901548
510k NumberK901548
Device Name:BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
ClassificationAnalyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Applicant SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
ContactAbati, Phd
CorrespondentAbati, Phd
SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
Product CodeCCC  
CFR Regulation Number868.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-03
Decision Date1991-01-14

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