FDA 510(k) Application Details - K991765

Device Classification Name Coil, Magnetic Resonance, Specialty

  More FDA Info for this Device
510(K) Number K991765
Device Name Coil, Magnetic Resonance, Specialty
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
P.O. BOX 860
SHELTON, CT 06484-0197 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 MOS
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 05/24/1999
Decision Date 08/02/1999
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