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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
510(k) Number K900860
Device Name PERFUSION MONITOR
Applicant
Cardio Metrics, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Applicant Contact R WILKINSON
Correspondent
Cardio Metrics, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Correspondent Contact R WILKINSON
Regulation Number870.4410
Classification Product Code
DTY  
Date Received02/23/1990
Decision Date 08/14/1990
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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