FDA 510(k) Application Details - K981131

Device Classification Name

  More FDA Info for this Device
510(K) Number K981131
Device Name PATHFINDER MOBILE C ARM
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

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

  More FDA Info for this Product Code
Date Received 03/30/1998
Decision Date 06/26/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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