FDA 510(k) Application Details - K180761

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K180761
Device Name	Electrode, Cortical
Applicant	micromed S.p.A. Via Giotto 2 Mogliano Veneto 31021 IT Other 510(k) Applications for this Company
Contact	Monica Camillo 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	03/23/2018
Decision Date	06/18/2018
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