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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 K021389
Device Name BIOLOGICAL SOUND MONITOR (BSM) SENSOR
Applicant
Andromed, Inc.
4610 Chemin Du Bois-Franc
Saint Laurent, Quebec,  CA H4S 1A7
Applicant Contact GENEVIEVE HAMEL
Correspondent
Andromed, Inc.
4610 Chemin Du Bois-Franc
Saint Laurent, Quebec,  CA H4S 1A7
Correspondent Contact GENEVIEVE HAMEL
Regulation Number870.1875
Classification Product Code
DQD  
Date Received05/02/2002
Decision Date 10/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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