FDA 510(k) Application Details - K022567

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

  More FDA Info for this Device
510(K) Number K022567
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant ACUSON CORP.
1220 CHARLESTON RD.
MOUNTAIN VIEW, CA 94039-7393 US
Other 510(k) Applications for this Company
Contact JERRY W TSUTSUMI
Other 510(k) Applications for this Contact
Regulation Number 892.1550

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

  More FDA Info for this Product Code
Date Received 08/02/2002
Decision Date 08/13/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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