FDA 510(k) Application Details - K052293

Device Classification Name System, Nuclear Magnetic Resonance Imaging

  More FDA Info for this Device
510(K) Number K052293
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant GE MEDICAL SYSTEMS, LLC
P.O. BOX 414
MILWAUKEE, WI 53201 US
Other 510(k) Applications for this Company
Contact LARRY A KROGER, PH.D.
Other 510(k) Applications for this Contact
Regulation Number 892.1000

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

  More FDA Info for this Product Code
Date Received 08/23/2005
Decision Date 09/21/2005
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