FDA 510(k)

ALLONUS Tech Próteses

Número K: K241616 · 2024-12-17

Data da decisão2024-12-17

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ALLONUS Tech Prosthetics is the device name listed in this FDA 510(k) record. The listed applicant is Allonus Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K241616. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ALLONUS Tech Prosthetics?

ALLONUS Tech Prosthetics is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Allonus Tech Co., Ltd.. The 510(k) number is K241616.

When did ALLONUS Tech Prosthetics receive FDA 510(k) clearance?

ALLONUS Tech Prosthetics received FDA 510(k) clearance on 2024-12-17, under 510(k) number K241616.

Who is the listed applicant for ALLONUS Tech Prosthetics?

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

What is the FDA product code for ALLONUS Tech Prosthetics?

The FDA product code for ALLONUS Tech Prosthetics is NHA.

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Fonte oficial

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