FDA 510(k) Application Details - K151281

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

  More FDA Info for this Device
510(K) Number K151281
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD
3/F, A1 BLDG, DONGSHEN SIMA INDUSTRIAL AREA,
NO.33 SHENBEI ROAD
DONGGUAN 523560 CN
Other 510(k) Applications for this Company
Contact VICTOR WAN
Other 510(k) Applications for this Contact
Regulation Number 870.1130

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

  More FDA Info for this Product Code
Date Received 05/14/2015
Decision Date 06/30/2015
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