FDA 510(k) Application Details - K071204

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

  More FDA Info for this Device
510(K) Number K071204
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY, UT 84116 US
Other 510(k) Applications for this Company
Contact KIMBERLY GEISLER
Other 510(k) Applications for this Contact
Regulation Number 892.1560

  More FDA Info for this Regulation Number
Classification Product Code IYO
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 05/01/2007
Decision Date 05/18/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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