QVN — Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus Class II
FDA product code QVN covers "Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus", a Class II medical device regulated under 21 CFR 874.3410. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QVN
- Device Class
- Class II
- Regulation Number
- 874.3410
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN210033 | neuromod devices limited | Lenire Tinnitus Treatment Device | March 6, 2023 |