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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 K121617
Device Name SENSICARDIAC
Applicant
Diacoustic Medical (Pty)
1468 Harwell Ave.,
Crofton,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
Diacoustic Medical (Pty)
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number870.1875
Classification Product Code
DQD  
Date Received06/01/2012
Decision Date 07/27/2012
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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