DCX一次性卡式碟 (DCX)
K 號：K243998 · 2025-04-25
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器材摘要
DCX Disposable Cassette (DCX) is the device name listed in this FDA 510(k) record. The listed applicant is Institut Geroges Lopez. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243998. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DCX Disposable Cassette (DCX)?
DCX Disposable Cassette (DCX) is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Institut Geroges Lopez. The 510(k) number is K243998.
When did DCX Disposable Cassette (DCX) receive FDA 510(k) clearance?
DCX Disposable Cassette (DCX) received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243998.
Who is the listed applicant for DCX Disposable Cassette (DCX)?
The FDA 510(k) record lists Institut Geroges Lopez as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DCX Disposable Cassette (DCX)?
The FDA product code for DCX Disposable Cassette (DCX) is KDN.
相關臨床試驗
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相關器械（代碼：KDN）
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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