FDA 510(k) Application Details - K082404

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K082404
Device Name	Electrode, Depth
Applicant	WE SENSE LTD 2 EKSAL ST PO BOX 50736 NAZARETH 16000 IL Other 510(k) Applications for this Company
Contact	NABIL JADAON Other 510(k) Applications for this Contact
Regulation Number	882.1330   More FDA Info for this Regulation Number
Classification Product Code	GZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2008
Decision Date	02/25/2009
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