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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K950760
Device Name ANALYST, MODEL DSP 300
Applicant
Heart Sounds, Inc.
15 Cheval Drivce
Don Mills, Toronto, Ontario
M3b 1r15,  CA
Applicant Contact HART KATZ
Correspondent
Heart Sounds, Inc.
15 Cheval Drivce
Don Mills, Toronto, Ontario
M3b 1r15,  CA
Correspondent Contact HART KATZ
Regulation Number870.1875
Classification Product Code
DQD  
Date Received02/17/1995
Decision Date 10/31/1995
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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