真實提升DL醫療設備規範文本： 「本產品已通過FDA（美國食品藥品管理局）的510(k)認證，並符合PMA（上市前批准）標準。該產品參與的臨床試驗代號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。請參考以下識別碼和URL以獲取更多資訊：[識別碼] [URL]。」 Note: The placeholders [識別碼] and [URL] should be replaced with the actual identifiers and URLs.
K 號：K233698 · 2024-04-11
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器材摘要
True Enhance DL is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2024-04-11 under 510(k) number K233698. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the True Enhance DL?
True Enhance DL is a medical device that received FDA 510(k) clearance on 2024-04-11. The listed applicant is Ge Healthcare Japan Corporation. The 510(k) number is K233698.
When did True Enhance DL receive FDA 510(k) clearance?
True Enhance DL received FDA 510(k) clearance on 2024-04-11, under 510(k) number K233698.
Who is the listed applicant for True Enhance DL?
The FDA 510(k) record lists Ge Healthcare Japan Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for True Enhance DL?
The FDA product code for True Enhance DL is JAK.
相關臨床試驗
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。
其他以 Ge Healthcare Japan Corporation 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。
相關器械（代碼：JAK）
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
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。
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