FDA 510(k)

膀胱AI（AIBV01）

K 號：K230497 · 2023-06-22

決定日期2023-06-22

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Exo, Inc. 為申請人之記錄

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相關器械（代碼：QIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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