FDA 510(k) Application Details - K963851

Device Classification Name Table, Radiographic, Tilting

  More FDA Info for this Device
510(K) Number K963851
Device Name Table, Radiographic, Tilting
Applicant ACOMA MEDICAL IMAGING, INC.
150 CHADDICK DR.
WHEELING, IL 60090 US
Other 510(k) Applications for this Company
Contact JAMES LAMBRECHT
Other 510(k) Applications for this Contact
Regulation Number 892.1980

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

  More FDA Info for this Product Code
Date Received 09/25/1996
Decision Date 01/23/1997
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