PreXion3D 探險版
K 號：K222150 · 2023-01-12
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器材摘要
PreXion3D Expedition is the device name listed in this FDA 510(k) record. The listed applicant is Prexion Corporation. It received FDA 510(k) clearance on 2023-01-12 under 510(k) number K222150. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PreXion3D Expedition?
PreXion3D Expedition is a medical device that received FDA 510(k) clearance on 2023-01-12. The listed applicant is Prexion Corporation. The 510(k) number is K222150.
When did PreXion3D Expedition receive FDA 510(k) clearance?
PreXion3D Expedition received FDA 510(k) clearance on 2023-01-12, under 510(k) number K222150.
Who is the listed applicant for PreXion3D Expedition?
The FDA 510(k) record lists Prexion Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PreXion3D Expedition?
The FDA product code for PreXion3D Expedition is OAS.
相關臨床試驗
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。
其他以 Prexion Corporation 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：OAS）
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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