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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
Predetermined Change
Control Plan Authorized		 No
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