FDA 510(k) Application Details - K033662

Device Classification Name Coil, Magnetic Resonance, Specialty

  More FDA Info for this Device
510(K) Number K033662
Device Name Coil, Magnetic Resonance, Specialty
Applicant PHILIPS MEDICAL SYSTEMS, INC.
595 MINER RD.
HIGHLAND HGTS., OH 44143 US
Other 510(k) Applications for this Company
Contact DUANE C PRASCHAN
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 11/21/2003
Decision Date 02/02/2004
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