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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 K860808
Device Name CONTINUCATH
Applicant
Orange Medical Instruments, Inc.
P.O. Box 88, George St.
High Wycombe
Buckinghamshire, England,  GB HP112RZ
Applicant Contact B. C CRANE
Correspondent
Orange Medical Instruments, Inc.
P.O. Box 88, George St.
High Wycombe
Buckinghamshire, England,  GB HP112RZ
Correspondent Contact B. C CRANE
Regulation Number868.1200
Classification Product Code
CCE  
Date Received03/04/1986
Decision Date 03/13/1986
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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