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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 K925524
Device Name CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)
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 Received11/02/1992
Decision Date 08/23/1993
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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