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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K862069
Device Name CARDIOMET 4000 GAS MONITORING SYSTEMS
Applicant
Biomedical Sensors, Inc.
P.O. Box 88, George St.
High Wycombe
Buckinghamshire, England,  GB HP112RZ
Applicant Contact B. C CRANE
Correspondent
Biomedical Sensors, Inc.
P.O. Box 88, George St.
High Wycombe
Buckinghamshire, England,  GB HP112RZ
Correspondent Contact B. C CRANE
Regulation Number870.4330
Classification Product Code
DRY  
Date Received05/30/1986
Decision Date 07/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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