FDA 510(k)

Hygenix

Número K: K232797 · 2023-12-11

RequerenteShenzhen Hygenix Industrial Co., Ltd.

Data da decisão2023-12-11

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hygenix is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Hygenix Industrial Co., Ltd.. It received FDA 510(k) clearance on 2023-12-11 under 510(k) number K232797. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hygenix?

Hygenix is a medical device that received FDA 510(k) clearance on 2023-12-11. The listed applicant is Shenzhen Hygenix Industrial Co., Ltd.. The 510(k) number is K232797.

When did Hygenix receive FDA 510(k) clearance?

Hygenix received FDA 510(k) clearance on 2023-12-11, under 510(k) number K232797.

Who is the listed applicant for Hygenix?

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

What is the FDA product code for Hygenix?

The FDA product code for Hygenix is FXX.

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