FDA 510(k)

Cleo

K 號：K232011 · 2023-07-07

決定日期2023-07-07

產品代碼NJM

諮詢委員會DE

決定相當於

器材摘要

Cleo is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 2023-07-07 under 510(k) number K232011. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cleo?

Cleo is a medical device that received FDA 510(k) clearance on 2023-07-07. The listed applicant is American Orthodontics. The 510(k) number is K232011.

When did Cleo receive FDA 510(k) clearance?

Cleo received FDA 510(k) clearance on 2023-07-07, under 510(k) number K232011.

Who is the listed applicant for Cleo?

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

What is the FDA product code for Cleo?

The FDA product code for Cleo is NJM.

其他以 American Orthodontics 為申請人之記錄

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相關器械（代碼：NJM）

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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