FDA 510(k) Application Details - K211452

Device Classification Name	Automatic Event Detection Software For Full-Montage Electroencephalograph   More FDA Info for this Device
510(K) Number	K211452
Device Name	Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant	Austrian Institute of Technology GmbH Giefinggasse 4 Vienna 1210 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	05/10/2021
Decision Date	12/02/2021
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