FDA 510(k)

Flex Fit

Número K: K190790 · 2020-07-31

Data da decisão2020-07-31

Código do produtoEBI

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Flex Fit is the device name listed in this FDA 510(k) record. The listed applicant is Dk Mungyo Corporation. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K190790. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Flex Fit?

Flex Fit is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Dk Mungyo Corporation. The 510(k) number is K190790.

When did Flex Fit receive FDA 510(k) clearance?

Flex Fit received FDA 510(k) clearance on 2020-07-31, under 510(k) number K190790.

Who is the listed applicant for Flex Fit?

The FDA 510(k) record lists Dk Mungyo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flex Fit?

The FDA product code for Flex Fit is EBI.

Dispositivos Relacionados (Código: EBI)

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Fonte oficial

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