Panels › Ear, Nose, Throat › Product code SCR · Class 2
Air-Conduction Hearing Aid Software
Regulation 874.3335
2510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SCR
| Company | 510(k)s | Recalls |
|---|---|---|
| Apple, Inc. | 1 | 0 |
| Luxottica Group S.P.A. | 1 | 0 |
| Meta Platform Technologies, LLC | 1 | 0 |
| Samsung Electronics Co., Ltd. | 1 | 0 |
| Tuned , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2026 | K261187 | Hearing Aid Feature Samsung Electronics Co., Ltd., KR | SCR |
| Jul 13, 2026 | K254044 | Hearing assist Meta Platform Technologies, LLC | SCR |
| Sep 26, 2025 | K251208 | Tuned Self-Fitting Mobile App Tuned , Ltd., IL | SCR |
| Jan 31, 2025 | K243150 | Nuance Audio Hearing Aid Software Luxottica Group S.P.A., IT | SCR |
| Sep 12, 2024 | DEN230081 | Hearing Aid Feature (HAF) Apple, Inc. | SCR |
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