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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 K853786
Device Name OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-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 Received09/10/1985
Decision Date 10/16/1985
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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