510(k) K251208
- Device
- Tuned Self-Fitting Mobile App
- Applicant
- Tuned , Ltd.
- 510(k) number
- K251208
- Product code
- SCR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-26
- Date received
- 2025-04-18
- Regulation
- 874.3335
- Classification name
- Air-Conduction Hearing Aid Software
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Omri Gavish
- Address
- 18 Harimon St. Gan Yoshiya IL 3885000 3885000
FDA Registration Numbers#
- 3014343954
- 3023339161
- 3011016506
- 9617804
Source Documents#
Other 510(k) Records For Product Code SCR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | 2026-07-31 |
| K254044 | Hearing assist | Meta Platform Technologies, LLC | 2026-07-13 |
| K243150 | Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. | 2025-01-31 |
| DEN230081 | Hearing Aid Feature (HAF) | Apple, Inc. | 2024-09-12 |