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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 K872125
Device Name BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM
Applicant
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876 -1234
Applicant Contact JOSEPH KICEINA
Correspondent
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876 -1234
Correspondent Contact JOSEPH KICEINA
Regulation Number868.1200
Classification Product Code
CCE  
Date Received06/02/1987
Decision Date 12/11/1987
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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