FDA 510(k) Application Details - K170959

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K170959
Device Name	Electrode, Depth
Applicant	DIXI Medical 2A route de Pouligney Chaudefontaine FR Other 510(k) Applications for this Company
Contact	Lucie Petegnief Other 510(k) Applications for this Contact
Regulation Number	882.1330   More FDA Info for this Regulation Number
Classification Product Code	GZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2017
Decision Date	11/24/2017
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