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FDA 510(k) Application Details - K010729
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K010729
Device Name
Stethoscope, Electronic
Applicant
ANDROMED, INC.
4610 CHEMIN DU BOIS-FRANC
SAINT LAURENT, QUEBEC H4S 1A7 CA
Other 510(k) Applications for this Company
Contact
JULIA LALE AKTIK
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
03/12/2001
Decision Date
10/26/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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