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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, gas, carbon-dioxide, partial pressure, blood-phase, indwelling
510(k) Number K901548
Device Name BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
Original Applicant
SHILEY, INC.
17600 gillette ave.
p.o. box 19503
irvine,  CA  92714
Original Contact abati, phd
Regulation Number868.1150
Classification Product Code
CCC  
Date Received04/03/1990
Decision Date 01/14/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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