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FDA 510(k) Application Details - K062481
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K062481
Device Name
Stethoscope, Electronic
Applicant
PISHON HIGH TECH CO., LTD.
P.O. BOX 7007
DEERFIELD, IL 60015 US
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Contact
DANIEL KAMM
Other 510(k) Applications for this Contact
Regulation Number
870.1875
More FDA Info for this Regulation Number
Classification Product Code
DQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/24/2006
Decision Date
10/16/2006
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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