O-掃描器
K 號：K183685 · 2019-01-22
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器材摘要
O-Scan is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2019-01-22 under 510(k) number K183685. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the O-Scan?
O-Scan is a medical device that received FDA 510(k) clearance on 2019-01-22. The listed applicant is Esaote, S.p.A.. The 510(k) number is K183685.
When did O-Scan receive FDA 510(k) clearance?
O-Scan received FDA 510(k) clearance on 2019-01-22, under 510(k) number K183685.
Who is the listed applicant for O-Scan?
FDA 510(k) 記錄將 Esaote, S.p.A. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for O-Scan?
The FDA product code for O-Scan is LNH.
其他以 Esaote, S.p.A. 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：LNH）
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
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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