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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K882593
Device Name MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM
Applicant
Cardio Metrics, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Applicant Contact MICHAEL J BILLIG
Correspondent
Cardio Metrics, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Correspondent Contact MICHAEL J BILLIG
Regulation Number870.2100
Classification Product Code
DPW  
Date Received06/24/1988
Decision Date 08/29/1988
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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