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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 K001306
Device Name STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
Applicant
Andromed, Inc.
2310 Boul Alfred-Nobel
St.Laurent, Quebec,  CA H4S 2A4
Applicant Contact JEAN DUMAS
Correspondent
Andromed, Inc.
2310 Boul Alfred-Nobel
St.Laurent, Quebec,  CA H4S 2A4
Correspondent Contact JEAN DUMAS
Regulation Number870.1875
Classification Product Code
DQD  
Date Received04/25/2000
Decision Date 07/20/2000
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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