FDA 510(k)

預成型藍色

K 號：K221575 · 2022-10-07

決定日期2022-10-07

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

Pre-Formed Blue is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K221575. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pre-Formed Blue?

Pre-Formed Blue is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Lake Region Medical. The 510(k) number is K221575.

When did Pre-Formed Blue receive FDA 510(k) clearance?

Pre-Formed Blue received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221575.

Who is the listed applicant for Pre-Formed Blue?

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

What is the FDA product code for Pre-Formed Blue?

The FDA product code for Pre-Formed Blue is DQX.

其他以 Lake Region Medical 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：DQX）

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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