超視覺2™ 電子筆
K 號：K240868 · 2024-08-12
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器材摘要
Ultravision2™ IonPencil is the device name listed in this FDA 510(k) record. The listed applicant is Alesi Surgical Limited. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K240868. The device is classified under product code PQM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ultravision2™ IonPencil?
Ultravision2™ IonPencil is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Alesi Surgical Limited. The 510(k) number is K240868.
When did Ultravision2™ IonPencil receive FDA 510(k) clearance?
Ultravision2™ IonPencil received FDA 510(k) clearance on 2024-08-12, under 510(k) number K240868.
Who is the listed applicant for Ultravision2™ IonPencil?
The FDA 510(k) record lists Alesi Surgical Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ultravision2™ IonPencil?
The FDA product code for Ultravision2™ IonPencil is PQM.
相關臨床試驗
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相關器械（代碼：PQM）
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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