FDA 510(k)

Cortium™

K 號：K230614 · 2023-05-02

決定日期2023-05-02

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Cortium™ is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K230614. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cortium™?

Cortium™ is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Ulrich Medical USA. The 510(k) number is K230614.

When did Cortium™ receive FDA 510(k) clearance?

Cortium™ received FDA 510(k) clearance on 2023-05-02, under 510(k) number K230614.

Who is the listed applicant for Cortium™?

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

What is the FDA product code for Cortium™?

The FDA product code for Cortium™ is NKG.

其他以 Ulrich Medical USA 為申請人之記錄

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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相關器械（代碼：NKG）

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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