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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, Oxygen, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K884063
Device Name BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
Applicant
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876
Applicant Contact KEVIN E DALY
Correspondent
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876
Correspondent Contact KEVIN E DALY
Regulation Number868.1200
Classification Product Code
CCE  
Date Received09/26/1988
Decision Date 12/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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