FDA 510(k) Application Details - K043030

Device Classification Name System, Nuclear Magnetic Resonance Imaging

  More FDA Info for this Device
510(K) Number K043030
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant SIEMENS MEDICAL SOLUTIONS
51 VALLEY STREAM PARKWAY E50
MALVERN, PA 19355 US
Other 510(k) Applications for this Company
Contact NEALIE HARTMAN
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 11/03/2004
Decision Date 12/09/2004
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 N
Expedited Review



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