FDA 510(k)

MCG-S (AM1000)

Número K: K232823 · 2024-04-05

Data da decisão2024-04-05

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

MCG-S (AM1000) is the device name listed in this FDA 510(k) record. The listed applicant is Amcg Co., Ltd.. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K232823. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MCG-S (AM1000)?

MCG-S (AM1000) is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Amcg Co., Ltd.. The 510(k) number is K232823.

When did MCG-S (AM1000) receive FDA 510(k) clearance?

MCG-S (AM1000) received FDA 510(k) clearance on 2024-04-05, under 510(k) number K232823.

Who is the listed applicant for MCG-S (AM1000)?

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

What is the FDA product code for MCG-S (AM1000)?

The FDA product code for MCG-S (AM1000) is DPS.

Dispositivos Relacionados (Código: DPS)

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Fonte oficial

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