FDA 510(k)

Self-Fitting hearing aids

Numéro K : K221052 · 2023-09-25

DemandeurHuizhou Jinghao Medical Technology Co., Ltd.

Date de décision2023-09-25

Code produitQUH

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Huizhou Jinghao Medical Technology Co., Ltd.. The 510(k) number is K221052.

When did Self-Fitting hearing aids receive FDA 510(k) clearance?

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

Who is the listed applicant for Self-Fitting hearing aids?

The FDA 510(k) record lists Huizhou Jinghao Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : QUH)

K254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)GN Hearing A/S K233747Concha Sol Hearing Aids (CL-1001)Concha Labs K233464WSA Self-Fitting Hearing Aid Gen 2Wsaud A/S K231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLC K223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned , Ltd.K230538All-Day Clear Slim ADCS1 Aid auditif. All-Day Clear ADC1 Aid auditifSonova AG

Source officielle

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