FDA 510(k) Application Details - K152947

Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)

  More FDA Info for this Device
510(K) Number K152947
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant TIGER MEDICAL PRODUCTS
JAJE PLAZA, SUITE 703, 1717 NORTH SICHUAN ROAD
Shanghai 200080 CN
Other 510(k) Applications for this Company
Contact Veronica Lee
Other 510(k) Applications for this Contact
Regulation Number 870.2900

  More FDA Info for this Regulation Number
Classification Product Code DSA
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/06/2015
Decision Date 04/05/2016
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