FDA 510(k) Application Details - K022896

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K022896
Device Name System, Image Processing, Radiological
Applicant ACUSON CORP.
1220 CHARLESTON RD.
MOUNTAIN VIEW, CA 94039-7393 US
Other 510(k) Applications for this Company
Contact BOB LEIKER
Other 510(k) Applications for this Contact
Regulation Number 892.2050

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

  More FDA Info for this Product Code
Date Received 09/03/2002
Decision Date 10/03/2002
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