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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 K872896
Device Name UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100
Applicant
AMERICAN BENTLEY
17502 ARMSTRONG AVE.
IRVINE,  CA  92714
Applicant Contact DONALD A RAIBLE
Correspondent
AMERICAN BENTLEY
17502 ARMSTRONG AVE.
IRVINE,  CA  92714
Correspondent Contact DONALD A RAIBLE
Regulation Number868.1200
Classification Product Code
CCE  
Date Received07/23/1987
Decision Date 02/12/1988
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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