免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

LX9max

K 號:K203498 · 2021-07-02

決定日期2021-07-02
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

LX9max is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K203498. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LX9max?

LX9max is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K203498.

When did LX9max receive FDA 510(k) clearance?

LX9max received FDA 510(k) clearance on 2021-07-02, under 510(k) number K203498.

Who is the listed applicant for LX9max?

The FDA 510(k) record lists Daesung Maref Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LX9max?

The FDA product code for LX9max is IRP.

其他以 Daesung Maref Co., Ltd. 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。

查看所有 10 項裝置 →

相關器械(代碼:IRP)

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑