FDA Product Code
FDA Product Code SCR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3335
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | 2026-07-31 | Traditional | PDF ↗ |
| K254044 | Hearing assist | Meta Platform Technologies, LLC | 2026-07-13 | Traditional | PDF ↗ |
| K251208 | Tuned Self-Fitting Mobile App | Tuned , Ltd. | 2025-09-26 | Traditional | PDF ↗ |
| K243150 | Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. | 2025-01-31 | Traditional | PDF ↗ |
| DEN230081 | Hearing Aid Feature (HAF) | Apple, Inc. | 2024-09-12 | Direct | — |
Product code SCR · Class II · Ear, Nose, Throat. Data: openFDA.