Lenire Tinnitus Treatment Device
FDA 510(k) clearance DEN210033 · decided 2023-03-06
Clearance details
- K-number
- DEN210033
- Device name
- Lenire Tinnitus Treatment Device
- Applicant
- Neuromod Devices Limited
- Decision
- Unknown
- Date received
- 2021-08-18
- Decision date
- 2023-03-06
- Days to decision
- 565 days
- Clearance type
- Direct
- Product code
- QVN
- Device class
- 2
- Regulation number
- 874.3410
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Dublin 8, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.