FDA 510(k) Application Details - K021780

Device Classification Name System, Simulation, Radiation Therapy

  More FDA Info for this Device
510(K) Number K021780
Device Name System, Simulation, Radiation Therapy
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS
3000 NORTH GRANDVIEW BLVD.
WAUKESHA, WI 53188 US
Other 510(k) Applications for this Company
Contact LARRY A KROGER
Other 510(k) Applications for this Contact
Regulation Number 892.5840

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

  More FDA Info for this Product Code
Date Received 05/30/2002
Decision Date 07/29/2002
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 Y
Expedited Review



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