FDA 510(k) Application Details - K201931

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K201931
Device Name	Electrode, Cortical
Applicant	Dixi Medical 2A Route de Pouligney Chaudefontaine 25640 FR Other 510(k) Applications for this Company
Contact	Lucie Petegnief 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	07/13/2020
Decision Date	10/02/2021
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