FDA 510(k) Application Details - K014147

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K014147
Device Name	Electroencephalograph
Applicant	XLTEK 2568 BRISTOL CIRCLE OAKVILLE L6H 5S1 CA Other 510(k) Applications for this Company
Contact	SONJA MARKEZ 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	12/18/2001
Decision Date	01/14/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review