FDA 510(k)

Levator Elite (Model LE9011)

Número K: K213043 · 2022-02-25

RequerenteShenzhen Dongdixin Technology Co., Ltd.

Data da decisão2022-02-25

Código do produtoIPF

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Levator Elite (Model LE9011) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K213043. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Levator Elite (Model LE9011)?

Levator Elite (Model LE9011) is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K213043.

When did Levator Elite (Model LE9011) receive FDA 510(k) clearance?

Levator Elite (Model LE9011) received FDA 510(k) clearance on 2022-02-25, under 510(k) number K213043.

Who is the listed applicant for Levator Elite (Model LE9011)?

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

What is the FDA product code for Levator Elite (Model LE9011)?

The FDA product code for Levator Elite (Model LE9011) is IPF.

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Fonte oficial

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