FDA 510(k) Application Details - K052571

Device Classification Name System, Nuclear Magnetic Resonance Imaging

  More FDA Info for this Device
510(K) Number K052571
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant NEUROGNOSTICS, INC.
10437 INNOVATION DR.
SUITE 309
MILWAUKEE, WI 53226 US
Other 510(k) Applications for this Company
Contact Hrishikesh Gadagkar
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 09/19/2005
Decision Date 10/17/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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