FDA 510(k) Application Details - K212936

Device Classification Name	Stimulator, Photic, Evoked Response   More FDA Info for this Device
510(K) Number	K212936
Device Name	Stimulator, Photic, Evoked Response
Applicant	Metrovision 4 rue des Platanes Perenchies 59840 FR Other 510(k) Applications for this Company
Contact	Jacques Charlier Other 510(k) Applications for this Contact
Regulation Number	882.1890   More FDA Info for this Regulation Number
Classification Product Code	GWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2021
Decision Date	11/21/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review