FDA 510(k) Application Details - K173684

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K173684
Device Name	Electrode, Cortical
Applicant	g.tec medical engineering GmbH Siemingerstrasse 14 Schiedlberg 4521 AU Other 510(k) Applications for this Company
Contact	Christoph Guger Other 510(k) Applications for this Contact
Regulation Number	882.1310   More FDA Info for this Regulation Number
Classification Product Code	GYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2017
Decision Date	05/04/2018
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	Y
Expedited Review