FDA 510(k) Application Details - K011485

Device Classification Name System, Nuclear Magnetic Resonance Imaging

  More FDA Info for this Device
510(K) Number K011485
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant FONAR CORP.
110 MARCUS DR., 102 MARCUS DR.
& 405 SMITH ST.
MELVILLE, NY 11747 US
Other 510(k) Applications for this Company
Contact LUCIANO BONANNI
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 05/15/2001
Decision Date 06/06/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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