FDA 510(k) Application Details - K031119

Device Classification Name Coil, Magnetic Resonance, Specialty

  More FDA Info for this Device
510(K) Number K031119
Device Name Coil, Magnetic Resonance, Specialty
Applicant MAYO MEDICAL VENTURES
200 FIRST ST SW
ROCHESTER, MN 55905 US
Other 510(k) Applications for this Company
Contact JADE SADOSTY
Other 510(k) Applications for this Contact
Regulation Number 892.1000

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

  More FDA Info for this Product Code
Date Received 04/08/2003
Decision Date 07/15/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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