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FDA 510(k)

Self-Fitting hearing aids

N.º K: K221052 · 2023-09-25

SolicitanteHuizhou Jinghao Medical Technology Co., Ltd.
Fecha de decisión2023-09-25
Código de productoQUH
Comité asesorEN
DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Dispositivos relacionados (Código: QUH)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)GN Hearing A/SK233747Concha Sol Hearing Aids (CL-1001)Concha LabsK233464WSA Self-Fitting Hearing Aid Gen 2Wsaud A/SK231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLCK223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned , Ltd.K230538Auricular Aparato Auditivo All-Day Clear Slim ADCS1. Aparato Auditivo All-Day Clear ADC1Sonova AG

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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