FDA 510(k) Application Details - K200878

Device Classification Name	Automatic Event Detection Software For Full-Montage Electroencephalograph   More FDA Info for this Device
510(K) Number	K200878
Device Name	Automatic Event Detection Software For Full-Montage 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	Sanjay Mehta Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2020
Decision Date	05/18/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review