FDA 510(k) Application Details - K090277

Device Classification Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K090277
Device Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant	EXCEL-TECH LTD. (XLTEK) 2568 BRISTOL CIR. OAKVILLE, ONTARIO L6H 5S1 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	OLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2009
Decision Date	04/19/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review