FDA 510(k) Application Details - K051765

Device Classification Name System, X-Ray, Tomography, Computed

  More FDA Info for this Device
510(K) Number K051765
Device Name System, X-Ray, Tomography, Computed
Applicant NEUROLOGICA CORPORATION
14 ELECTRONICS AVENUE
DANVERS, MA 01923 US
Other 510(k) Applications for this Company
Contact BRAHIM HADRI
Other 510(k) Applications for this Contact
Regulation Number 892.1750

  More FDA Info for this Regulation Number
Classification Product Code JAK
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/30/2005
Decision Date 07/14/2005
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 Y
Expedited Review



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