FDA 510(k) Application Details - K003516

Device Classification Name System, Nuclear Magnetic Resonance Imaging

  More FDA Info for this Device
510(K) Number K003516
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON, CT 06484 US
Other 510(k) Applications for this Company
Contact PETER ALTMAN
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 11/14/2000
Decision Date 12/27/2000
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