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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 K121144
Device Name ELECTRONIC STETHOSCOPE
Applicant
Sharp Corporation
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Applicant Contact DIANE RUTHERFORD
Correspondent
Sharp Corporation
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number870.1875
Classification Product Code
DQD  
Date Received04/16/2012
Decision Date 09/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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