FDA 510(k) Application Details - K060895

Device Classification Name Accelerator, Linear, Medical

  More FDA Info for this Device
510(K) Number K060895
Device Name Accelerator, Linear, Medical
Applicant NOMOS CORP.
200 WEST KENSINGER DR.
SUITE 100
CRANBERRY TOWNSHIP, PA 16066 US
Other 510(k) Applications for this Company
Contact LEIGH SPOTTEN
Other 510(k) Applications for this Contact
Regulation Number 892.5050

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

  More FDA Info for this Product Code
Date Received 04/03/2006
Decision Date 07/21/2006
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