FDA 510(k) Application Details - K093823

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

  More FDA Info for this Device
510(K) Number K093823
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant HEALTH & LIFE CO., LTD.
9F, NO.186, JIAN YI ROAD
CHUNG HO CITY, TAIPEI 235 TW
Other 510(k) Applications for this Company
Contact SARAH SU
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 12/14/2009
Decision Date 01/22/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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