FDA 510(k) Application Details - K223438

Device Classification Name	More FDA Info for this Device
510(K) Number	K223438
Device Name	TELIGEN System Peripheral Motor Nerve Stimulation Indications
Applicant	Medos International, SARL Chemin Blanc 38 Le Locle 2400 CH Other 510(k) Applications for this Company
Contact	Daria Bochenek Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2022
Decision Date	02/10/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review