FDA 510(k) Application Details - K013450

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K013450
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 300 WESTMOUNT, QUEBEC H3Z 2N2 CA Other 510(k) Applications for this Company
Contact	GEORGE PAPAGIANNIS Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2001
Decision Date	01/14/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review