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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phonocardiograph
510(k) Number K952651
Device Name LIFE SOUND SENSOR
Applicant
Flowscan, Inc.
75 Castenada Ave.
San Francisco,  CA  94116
Applicant Contact ROBERT L LOFTS
Correspondent
Flowscan, Inc.
75 Castenada Ave.
San Francisco,  CA  94116
Correspondent Contact ROBERT L LOFTS
Regulation Number870.2390
Classification Product Code
DQC  
Date Received06/09/1995
Decision Date 09/19/1995
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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