FDA 510(k) Application Details - K203419

Device Classification Name	More FDA Info for this Device
510(K) Number	K203419
Device Name	Relivion
Applicant	Neurolief Ltd. 12 Giborei Israel St. Netanya 4250412 IL Other 510(k) Applications for this Company
Contact	Michal Kedar-Datel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2020
Decision Date	02/16/2021
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