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FDA 510(k)

Self-Fitting hearing aids

K-Number: K221052 · 2023-09-25

ApplicantHuizhou Jinghao Medical Technology Co., Ltd.
Decision Date2023-09-25
Product CodeQUH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Self-Fitting hearing aids is a medical device manufactured by Huizhou Jinghao Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-25 under approval number K221052. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Self-Fitting hearing aids?

Self-Fitting hearing aids is a medical device that received FDA 510(k) clearance on 2023-09-25. It is manufactured by Huizhou Jinghao Medical Technology Co., Ltd.. The 510(k) number is K221052.

When was Self-Fitting hearing aids approved by the FDA?

Self-Fitting hearing aids received FDA 510(k) clearance on 2023-09-25, under approval number K221052.

What company makes Self-Fitting hearing aids?

Self-Fitting hearing aids is manufactured by Huizhou Jinghao Medical Technology Co., Ltd..

What is the FDA product code for Self-Fitting hearing aids?

The FDA product code for Self-Fitting hearing aids is QUH.

Related Clinical Trials

NCT06894303 Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up RECRUITING NCT03795675 CI Following VS Removal or Labyrinthectomy ACTIVE_NOT_RECRUITING NCT06309264 Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans RECRUITING

Related Devices (Code: QUH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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