FDA 510(k) Application Details - K221123

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K221123
Device Name	Electrode, Cortical
Applicant	WISE S.r.l. Via Michelangelo Buonarroti ,38 Cologno Monzese 20093 IT Other 510(k) Applications for this Company
Contact	Luca Ravagnan 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	04/18/2022
Decision Date	11/22/2022
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