FDA 510(k) Application Details - K060925

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

  More FDA Info for this Device
510(K) Number K060925
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant ACON LABORATORIES, INC.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
Contact EDWARD TUNG
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 04/04/2006
Decision Date 05/09/2006
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