3DIEMME RealGUIDE
K 號:K173041 · 2018-12-20
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器材摘要
3DIEMME RealGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is 3Diemme , Ltd.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K173041. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the 3DIEMME RealGUIDE?
3DIEMME RealGUIDE is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is 3Diemme , Ltd.. The 510(k) number is K173041.
When did 3DIEMME RealGUIDE receive FDA 510(k) clearance?
3DIEMME RealGUIDE received FDA 510(k) clearance on 2018-12-20, under 510(k) number K173041.
Who is the listed applicant for 3DIEMME RealGUIDE?
The FDA 510(k) record lists 3Diemme , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 3DIEMME RealGUIDE?
The FDA product code for 3DIEMME RealGUIDE is LLZ.
相關臨床試驗
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相關器械(代碼:LLZ)
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。
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