FDA 510(k)

Strain AI (SAI001)

K号: K242359 · 2024-11-20

决定日期2024-11-20

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Strain AI (SAI001) is the device name listed in this FDA 510(k) record. The listed applicant is Exo, Inc.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K242359. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Strain AI (SAI001)?

Strain AI (SAI001) is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Exo, Inc.. The 510(k) number is K242359.

When did Strain AI (SAI001) receive FDA 510(k) clearance?

Strain AI (SAI001) received FDA 510(k) clearance on 2024-11-20, under 510(k) number K242359.

Who is the listed applicant for Strain AI (SAI001)?

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

What is the FDA product code for Strain AI (SAI001)?

The FDA product code for Strain AI (SAI001) is QIH.

列明Exo, 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。

K243239Lung AI (LAI001)K232501AI平台（AIP001）K230497膀胱AI（AIBV01）

官方来源

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