FDA 510(k) Application Details - K160023

Device Classification Name Stethoscope, Electronic

  More FDA Info for this Device
510(K) Number K160023
Device Name Stethoscope, Electronic
Applicant IMEDIPLUS INC.
2F, 12, SHENGYI RD.SEC.2
CHUBEI CITY 30261 TW
Other 510(k) Applications for this Company
Contact SHIRLEY LAI
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 01/06/2016
Decision Date 09/30/2016
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



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