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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact