FDA 510(k) Application Details - K980306

Device Classification Name System, Nuclear Magnetic Resonance Imaging

  More FDA Info for this Device
510(K) Number K980306
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK, NJ 07601 US
Other 510(k) Applications for this Company
Contact STEVEN M KAY
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 01/27/1998
Decision Date 04/02/1998
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