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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
Model BM-520
Device Name ELECTRONIC STETHOSCOPE
Applicant
SHARP CORPORATION
1201 richardson drive
suite 280
richardson,  TX  75080
Contact diane rutherford
Regulation Number870.1875
Classification Product Code
DQD  
Date Received05/30/2012
Decision Date 09/26/2012
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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