FDA 510(k)

Venen-trainer (Model: FM150, SFM90)

Número K: K203746 · 2021-11-10

RequerenteShenzhen Pango Electronic Co., Ltd.

Data da decisão2021-11-10

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Venen-trainer (Model: FM150, SFM90) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Pango Electronic Co., Ltd.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K203746. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Venen-trainer (Model: FM150, SFM90)?

Venen-trainer (Model: FM150, SFM90) is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Shenzhen Pango Electronic Co., Ltd.. The 510(k) number is K203746.

When did Venen-trainer (Model: FM150, SFM90) receive FDA 510(k) clearance?

Venen-trainer (Model: FM150, SFM90) received FDA 510(k) clearance on 2021-11-10, under 510(k) number K203746.

Who is the listed applicant for Venen-trainer (Model: FM150, SFM90)?

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

What is the FDA product code for Venen-trainer (Model: FM150, SFM90)?

The FDA product code for Venen-trainer (Model: FM150, SFM90) is JOW.

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Fonte oficial

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