FDA 510(k) Application Details - K213049

Device Classification Name	Stimulator, Nerve, Battery-Powered   More FDA Info for this Device
510(K) Number	K213049
Device Name	Stimulator, Nerve, Battery-Powered
Applicant	Xavant Technology (Pty) Ltd Unit 102 Tannery Industrial Park, 309 Derdepoort Road Silverton Pretoria 0184 ZA Other 510(k) Applications for this Company
Contact	Roche Janse van Rensburg Other 510(k) Applications for this Contact
Regulation Number	868.2775   More FDA Info for this Regulation Number
Classification Product Code	BXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2021
Decision Date	10/16/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review