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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 K131044
Device Name SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
Applicant
Diacoustic Medical Devices (Pty) , Ltd.
1468 Harwell Ave.,
Crofton,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
Diacoustic Medical Devices (Pty) , Ltd.
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DQC  
Date Received04/15/2013
Decision Date 09/04/2013
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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