FDA 510(k) Application Details - K955251

Device Classification Name

  More FDA Info for this Device
510(K) Number K955251
Device Name OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
Applicant IMAGING SERVICES, INC.
1037 NORTH LIMA ST.
BURBANK, CA 91505 US
Other 510(k) Applications for this Company
Contact DEAN N JAMES
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 11/15/1995
Decision Date 04/12/1996
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