FDA 510(k) Application Details - K040195

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K040195
Device Name System, Image Processing, Radiological
Applicant WITT BIOMEDICAL CORP
305 NORTH DR.
MELBOURNE, FL 32934 US
Other 510(k) Applications for this Company
Contact ELFRIEDE PAGAN
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 01/28/2004
Decision Date 04/07/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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