FDA 510(k) Application Details - K212164

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K212164
Device Name	Stimulator, Nerve
Applicant	inomed Medizintechnik GmbH Im Hausgruen 29 Emmendingen 79312 DE Other 510(k) Applications for this Company
Contact	Alexander Maier Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2021
Decision Date	11/11/2022
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