D-LUX+
K 號:K200809 · 2020-08-07
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器材摘要
D-LUX+ is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K200809. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the D-LUX+?
D-LUX+ is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is DiaDent Group International. The 510(k) number is K200809.
When did D-LUX+ receive FDA 510(k) clearance?
D-LUX+ received FDA 510(k) clearance on 2020-08-07, under 510(k) number K200809.
Who is the listed applicant for D-LUX+?
FDA 510(k) 記錄將 DiaDent Group International 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for D-LUX+?
The FDA product code for D-LUX+ is EBZ.
其他以 DiaDent Group International 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:EBZ)
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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