FDA 510(k)

Aimanfun Lumea Comfort, Model: A-2788, A-2789 e A-3588

Número K: K230107 · 2023-04-05

RequerenteKam Yuen Plastic Products , Ltd.

Data da decisão2023-04-05

Código do produtoOHT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is the device name listed in this FDA 510(k) record. The listed applicant is Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K230107. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588?

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K230107.

When did Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 receive FDA 510(k) clearance?

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 received FDA 510(k) clearance on 2023-04-05, under 510(k) number K230107.

Who is the listed applicant for Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588?

The FDA 510(k) record lists Kam Yuen Plastic Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588?

The FDA product code for Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is OHT.

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Outros registros que listam Kam Yuen Plastic Products , Ltd. como candidato(a)

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