迪亞-塞姆
K 號：K231552 · 2023-07-28
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器材摘要
Dia-Cem 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 2023-07-28 under 510(k) number K231552. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Dia-Cem?
Dia-Cem is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is DiaDent Group International. The 510(k) number is K231552.
When did Dia-Cem receive FDA 510(k) clearance?
Dia-Cem received FDA 510(k) clearance on 2023-07-28, under 510(k) number K231552.
Who is the listed applicant for Dia-Cem?
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 Dia-Cem?
The FDA product code for Dia-Cem is EMA.
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：EMA）
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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