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FDA 510(k)

ERI Handheld Dental X-ray System (Model AG100)

Número K: K213282 · 2022-04-04

RequerenteEnergy Resources International Co., Ltd. Hsinchu Branch
Data da decisão2022-04-04
Código do produtoEHD
Comité consultivoDE
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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)

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