FDA 510(k)

Microcurrent device (Model: HBR2-1)

Número K: K211055 · 2021-11-05

RequerenteShenzhen DJ Medical Equipment Co., Ltd.

Data da decisão2021-11-05

Código do produtoNFO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Microcurrent device (Model: HBR2-1) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen DJ Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K211055. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Microcurrent device (Model: HBR2-1)?

Microcurrent device (Model: HBR2-1) is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Shenzhen DJ Medical Equipment Co., Ltd.. The 510(k) number is K211055.

When did Microcurrent device (Model: HBR2-1) receive FDA 510(k) clearance?

Microcurrent device (Model: HBR2-1) received FDA 510(k) clearance on 2021-11-05, under 510(k) number K211055.

Who is the listed applicant for Microcurrent device (Model: HBR2-1)?

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

What is the FDA product code for Microcurrent device (Model: HBR2-1)?

The FDA product code for Microcurrent device (Model: HBR2-1) is NFO.

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