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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K933320
Device Name CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT
Applicant
Cardio Metrics, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Applicant Contact SUSAN E OSBORNE
Correspondent
Cardio Metrics, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Correspondent Contact SUSAN E OSBORNE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/07/1993
Decision Date 08/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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