FDA 510(k) Application Details - K083577

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K083577
Device Name	Electroencephalograph
Applicant	STELLATE SYSTEMS 376 VICTORIA AVENUE, SUITE 200 MONTREAL, QUEBEC H3Z 1C3 CA Other 510(k) Applications for this Company
Contact	GOLDY SINGH 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	12/03/2008
Decision Date	08/29/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review