FDA 510(k) Application Details - K051258

Device Classification Name System, X-Ray, Stationary

  More FDA Info for this Device
510(K) Number K051258
Device Name System, X-Ray, Stationary
Applicant EASTMAN KODAK COMPANY
343 STATE STREET
ROCHESTER, NY 14650 US
Other 510(k) Applications for this Company
Contact CHRISTINE E EHMANN
Other 510(k) Applications for this Contact
Regulation Number 892.1680

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

  More FDA Info for this Product Code
Date Received 05/16/2005
Decision Date 06/01/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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