FDA 510(k) Application Details - K071118

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K071118
Device Name	Electrode, Cutaneous
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	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2007
Decision Date	09/07/2007
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