FDA 510(k) Application Details - DEN210033

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210033
Device Name	Lenire Tinnitus Treatment Device
Applicant	Neuromod Devices Limited Rainsford St. Dublin 8 D08 R2YP IE Other 510(k) Applications for this Company
Contact	Fran Coogan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2021
Decision Date	03/06/2023
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review