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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K870150
Device Name CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM
Applicant
CARDIOMETRICS, INC.
645 CLYDE AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact MICHAEL J BILLIG
Correspondent
CARDIOMETRICS, INC.
645 CLYDE AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MICHAEL J BILLIG
Regulation Number870.2880
Classification Product Code
JOP  
Date Received01/13/1987
Decision Date 08/07/1987
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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