FDA 510(k)

膀胱AI（AIBV01）

K号: K230497 · 2023-06-22

决定日期2023-06-22

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Bladder AI (AIBV01) is the device name listed in this FDA 510(k) record. The listed applicant is Exo, Inc.. It received FDA 510(k) clearance on 2023-06-22 under 510(k) number K230497. 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 Bladder AI (AIBV01)?

Bladder AI (AIBV01) is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is Exo, Inc.. The 510(k) number is K230497.

When did Bladder AI (AIBV01) receive FDA 510(k) clearance?

Bladder AI (AIBV01) received FDA 510(k) clearance on 2023-06-22, under 510(k) number K230497.

Who is the listed applicant for Bladder AI (AIBV01)?

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 Bladder AI (AIBV01)?

The FDA product code for Bladder AI (AIBV01) 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)K242359Strain AI (SAI001)K232501AI平台（AIP001）

官方来源

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