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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
Original Applicant
DIACOUSTIC MEDICAL (PTY)
1468 harwell ave
crofton,  MD  21114
Original Contact yolanda smith
Regulation Number870.1875
Classification Product Code
DQD  
Date Received06/01/2012
Decision Date 07/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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