FDA 510(k) Application Details - K013478

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

  More FDA Info for this Device
510(K) Number K013478
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant PULSE METRIC, INC.
11777 SORRENTO VALLEY RD.
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
Contact ROBERT DUFFY
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 10/19/2001
Decision Date 01/10/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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