FDA 510(k) K221052, Self-Fitting hearing aids, by Huizhou Jinghao Medical Technology Co., Ltd.
FDA 510(k) K221052, Self-Fitting hearing aids, by Huizhou Jinghao Medical Technology Co., Ltd.
| 510(k) Number | K221052 |
| Device Classification Name | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Device Name | Self-Fitting hearing aids |
| Applicant | Huizhou Jinghao Medical Technology Co., Ltd. Floor 6, Huicheng Industry Bldg., #9 Huifeng Dong'Er Rd. Zhongkai High-Tech Zone Huizhou, CN 516006 |
| Regulation Number | 874.3325 |
| Classification Product Code | QUH |
| Date Received | 04/11/2022 |
| Decision Date | 09/25/2023 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Ear Nose & Throat |
| 510k Review Panel | Ear Nose & Throat |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 3509 |
| Redacted Pages | 2872 |
| Unredacted Pages | 637 |
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