FDA 510(k) Application Details - K081430

Device Classification Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph

  More FDA Info for this Device
510(K) Number K081430
Device Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant ELEKTA NEUROMAG OY
P.O. BOX 68
DEERFIELD, IL 60015 US
Other 510(k) Applications for this Company
Contact DANIEL KAMM
Other 510(k) Applications for this Contact
Regulation Number 882.1400

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

  More FDA Info for this Product Code
Date Received 05/21/2008
Decision Date 07/28/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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