FDA 510(k) Application Details - K954589

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K954589
Device Name System, Image Processing, Radiological
Applicant CLARK RESEARCH AND DEVELOPMENT, INC.
NUMBER 13 PARK LN.
FOLSOM, LA 70437 US
Other 510(k) Applications for this Company
Contact MICHAEL S PEARL
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 10/03/1995
Decision Date 01/05/1996
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 N
Expedited Review



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