FDA 510(k) Application Details - K080888

Device Classification Name System,Planning,Radiation Therapy Treatment

  More FDA Info for this Device
510(K) Number K080888
Device Name System,Planning,Radiation Therapy Treatment
Applicant BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN 85622 DE
Other 510(k) Applications for this Company
Contact CARSTEN RAUPACH
Other 510(k) Applications for this Contact
Regulation Number 892.5050

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

  More FDA Info for this Product Code
Date Received 03/31/2008
Decision Date 06/11/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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