FDA 510(k)

CogNet AI-MT+

K号: K252482 · 2025-12-11

决定日期2025-12-11

产品代码QFM

咨询委员会RA

决定实质等同

器械摘要

CogNet AI-MT+ is the device name listed in this FDA 510(k) record. The listed applicant is Medcognetics, Inc.. It received FDA 510(k) clearance on 2025-12-11 under 510(k) number K252482. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CogNet AI-MT+?

CogNet AI-MT+ is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is Medcognetics, Inc.. The 510(k) number is K252482.

When did CogNet AI-MT+ receive FDA 510(k) clearance?

CogNet AI-MT+ received FDA 510(k) clearance on 2025-12-11, under 510(k) number K252482.

Who is the listed applicant for CogNet AI-MT+?

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

What is the FDA product code for CogNet AI-MT+?

The FDA product code for CogNet AI-MT+ is QFM.

列明Medcognetics, Inc.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。

K220080CogNet QmTRIAGE

官方来源

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