FDA 510(k) Application Details - K060401

Device Classification Name Coil, Magnetic Resonance, Specialty

  More FDA Info for this Device
510(K) Number K060401
Device Name Coil, Magnetic Resonance, Specialty
Applicant MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA, PA 15051 US
Other 510(k) Applications for this Company
Contact LISA A EWING
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 02/15/2006
Decision Date 03/15/2006
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