FDA 510(k) Application Details - K202234

Device Classification Name	Cuff, Nerve   More FDA Info for this Device
510(K) Number	K202234
Device Name	Cuff, Nerve
Applicant	Renerve Ltd Suite 3, 21 Vale Street North Melbourne 3051 AU Other 510(k) Applications for this Company
Contact	David Rhodes Other 510(k) Applications for this Contact
Regulation Number	882.5275   More FDA Info for this Regulation Number
Classification Product Code	JXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2020
Decision Date	02/10/2022
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