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FDA 510(k) Application Details - K110704
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K110704
Device Name
Stethoscope, Electronic
Applicant
DIACOUSTIC MEDICAL DEVICES (PTY) LTD.
1468 Harwell Avenue
Crofton, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
870.1875
More FDA Info for this Regulation Number
Classification Product Code
DQD
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More FDA Info for this Product Code
Date Received
03/14/2011
Decision Date
06/24/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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