FDA 510(k) Application Details - K173690

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K173690
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville L6H 5S1 CA Other 510(k) Applications for this Company
Contact	Shane Sawall 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	12/01/2017
Decision Date	03/09/2018
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