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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 K021087
Device Name HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE
Applicant
Erecords Limited
801 York Mills Rd.
Suite 314
Toronto,  CA M3B 1X7
Applicant Contact ED GOSS
Correspondent
Erecords Limited
801 York Mills Rd.
Suite 314
Toronto,  CA M3B 1X7
Correspondent Contact ED GOSS
Regulation Number870.1875
Classification Product Code
DQD  
Date Received04/03/2002
Decision Date 10/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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