FDA 510(k) Application Details - K212325

Device Classification Name	Media, Electroconductive   More FDA Info for this Device
510(K) Number	K212325
Device Name	Media, Electroconductive
Applicant	SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker 97236 DE Other 510(k) Applications for this Company
Contact	Sabrina Forster Other 510(k) Applications for this Contact
Regulation Number	882.1275   More FDA Info for this Regulation Number
Classification Product Code	GYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2021
Decision Date	06/15/2022
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