FDA 510(k) Application Details - K062533

Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software

  More FDA Info for this Device
510(K) Number K062533
Device Name Non-Normalizing Quantitative Electroencephalograph Software
Applicant NEUROVIRTUAL USA, INC.
2315 NW 107TH AVE.
BOX #133 WAREHOUSE 1A16
DORAL, FL 33172 US
Other 510(k) Applications for this Company
Contact EDUARDO FARIA
Other 510(k) Applications for this Contact
Regulation Number 882.1400

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

  More FDA Info for this Product Code
Date Received 08/29/2006
Decision Date 12/22/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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