FDA 510(k) Application Details - K042967

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

  More FDA Info for this Device
510(K) Number K042967
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant A & D ENGINEERING, INC.
1555 MCCANDLESS DR.
MILPITAS, CA 95035 US
Other 510(k) Applications for this Company
Contact JERRY WANG
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 10/28/2004
Decision Date 12/03/2004
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