FDA 510(k)

EFAI 神经套件CT ICH评估系统

K号: K231025 · 2023-10-04

决定日期2023-10-04

产品代码QAS

咨询委员会RA

决定实质等同

器械摘要

EFAI NeuroSuite CT ICH 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 2023-10-04 under 510(k) number K231025. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EFAI NeuroSuite CT ICH Assessment System?

EFAI NeuroSuite CT ICH Assessment System is a medical device that received FDA 510(k) clearance on 2023-10-04. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K231025.

When did EFAI NeuroSuite CT ICH Assessment System receive FDA 510(k) clearance?

EFAI NeuroSuite CT ICH Assessment System received FDA 510(k) clearance on 2023-10-04, under 510(k) number K231025.

Who is the listed applicant for EFAI NeuroSuite CT ICH 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 NeuroSuite CT ICH Assessment System?

The FDA product code for EFAI NeuroSuite CT ICH Assessment System is QAS.

列明Ever Fortune.Ai, Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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