FDA 510(k) Application Details - K171720

Device Classification Name	Automatic Event Detection Software For Full-Montage Electroencephalograph   More FDA Info for this Device
510(K) Number	K171720
Device Name	Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant	AIT Austrian Institute of Technology GmbH Donau-City-Strabe 1 Vienna 1220 AT Other 510(k) Applications for this Company
Contact	Tilmann Kluge 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	06/12/2017
Decision Date	04/19/2018
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