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FDA 510(k)

ERI Handheld Dental X-ray System (Model AG100)

N.º K: K213282 · 2022-04-04

SolicitanteEnergy Resources International Co., Ltd. Hsinchu Branch
Fecha de decisión2022-04-04
Código de productoEHD
Comité asesorDE
DecisiónSubstantially Equivalent

Resumen del dispositivo

ERI Handheld Dental X-ray System (Model AG100) is the device name listed in this FDA 510(k) record. The listed applicant is Energy Resources International Co., Ltd. Hsinchu Branch. It received FDA 510(k) clearance on 2022-04-04 under 510(k) number K213282. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ERI Handheld Dental X-ray System (Model AG100)?

ERI Handheld Dental X-ray System (Model AG100) is a medical device that received FDA 510(k) clearance on 2022-04-04. The listed applicant is Energy Resources International Co., Ltd. Hsinchu Branch. The 510(k) number is K213282.

When did ERI Handheld Dental X-ray System (Model AG100) receive FDA 510(k) clearance?

ERI Handheld Dental X-ray System (Model AG100) received FDA 510(k) clearance on 2022-04-04, under 510(k) number K213282.

Who is the listed applicant for ERI Handheld Dental X-ray System (Model AG100)?

The FDA 510(k) record lists Energy Resources International Co., Ltd. Hsinchu Branch as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERI Handheld Dental X-ray System (Model AG100)?

The FDA product code for ERI Handheld Dental X-ray System (Model AG100) is EHD.

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Dispositivos relacionados (Código: EHD)

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.

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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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