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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 K860106
Device Name OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
Applicant
AMERICAN BENTLEY
P.O. BOX 19522
IRVINE,  CA  92713
Applicant Contact DONALD A RAIBLE
Correspondent
AMERICAN BENTLEY
P.O. BOX 19522
IRVINE,  CA  92713
Correspondent Contact DONALD A RAIBLE
Regulation Number868.1200
Classification Product Code
CCE  
Date Received01/13/1986
Decision Date 02/26/1986
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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