FDA 510(k)

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

Número K: K241923 · 2024-12-06

Data da decisão2024-12-06

Código do produtoQAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) 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 2024-12-06 under 510(k) number K241923. 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 Neurosuite CT Midline Shift Assessment System (MLS-CT-100)?

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K241923.

When did EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) receive FDA 510(k) clearance?

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241923.

Who is the listed applicant for EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)?

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 Neurosuite CT Midline Shift Assessment System (MLS-CT-100)?

The FDA product code for EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is QAS.

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

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