FDA 510(k) Application Details - K964697

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

  More FDA Info for this Device
510(K) Number K964697
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant ADVANCE MEDICAL DEVICE, INC.
152 WEST WISCONSIN AVE.
MILWAUKEE, WI 53203 US
Other 510(k) Applications for this Company
Contact BRIAN W PETERSEN
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 11/22/1996
Decision Date 02/11/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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