510(k) DEN210033
- Device
- Lenire Tinnitus Treatment Device
- Applicant
- Neuromod Devices Limited
- 510(k) number
- DEN210033
- Product code
- QVN
- Decision
- Unknown (DENG)
- Decision date
- 2023-03-06
- Date received
- 2021-08-18
- Regulation
- 874.3410
- Classification name
- Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Fran Coogan
- Address
- Rainsford St. Dublin 8 IE D08 R2YP D08 R2YP
FDA Registration Numbers#
- 8020864
- 3018030059
Source Documents#
510(k) summary PDF not indicated by FDA