FDA 510(k) Application Details - K053386

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K053386
Device Name	Electroencephalograph
Applicant	EXCEL TECH. LTD. 2568 BRISTOL CIRCLE OAKVILLE, ONTARIO L6H 5S1 CA Other 510(k) Applications for this Company
Contact	NICOLE LANDREVILLE Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2005
Decision Date	04/21/2006
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