藍檢™ 齒菌檢測與監控
K 號：K222560 · 2023-05-16
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器材摘要
BlueCheck™ Caries Detection & Monitoring is the device name listed in this FDA 510(k) record. The listed applicant is Incisive Technologies Pty, Ltd.. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K222560. The device is classified under product code LFC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BlueCheck™ Caries Detection & Monitoring?
BlueCheck™ Caries Detection & Monitoring is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Incisive Technologies Pty, Ltd.. The 510(k) number is K222560.
When did BlueCheck™ Caries Detection & Monitoring receive FDA 510(k) clearance?
BlueCheck™ Caries Detection & Monitoring received FDA 510(k) clearance on 2023-05-16, under 510(k) number K222560.
Who is the listed applicant for BlueCheck™ Caries Detection & Monitoring?
The FDA 510(k) record lists Incisive Technologies Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BlueCheck™ Caries Detection & Monitoring?
The FDA product code for BlueCheck™ Caries Detection & Monitoring is LFC.
相關臨床試驗
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相關器械（代碼：LFC）
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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