FDA 510(k) Application Details - K062880

Device Classification Name	Electrode, Needle   More FDA Info for this Device
510(K) Number	K062880
Device Name	Electrode, Needle
Applicant	IVES EEG SOLUTIONS, INC. 6325 RIDEAU VALLEY DRIVE MANOTICK, ONTARIO K4M 1B3 CA Other 510(k) Applications for this Company
Contact	JOHN R IVES Other 510(k) Applications for this Contact
Regulation Number	882.1350   More FDA Info for this Regulation Number
Classification Product Code	GXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2006
Decision Date	12/22/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review