FDA 510(k)

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Número K: K240291 · 2024-04-08

Data da decisão2024-04-08

Código do produtoQAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2024-04-08 under 510(k) number K240291. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM?

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2024-04-08. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K240291.

When did EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM receive FDA 510(k) clearance?

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM received FDA 510(k) clearance on 2024-04-08, under 510(k) number K240291.

Who is the listed applicant for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM?

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

What is the FDA product code for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM?

The FDA product code for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is QAS.

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Outros registros que listam Ever Fortune.Ai, Co., Ltd. como candidato(a)

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Fonte oficial

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