AFS醫療無菌單次使用進入端口系統
K 號：K202688 · 2021-10-14
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器材摘要
AFS Medical Sterile Single-Use Access Port System is the device name listed in this FDA 510(k) record. The listed applicant is Afs Medical Co. , Ltd.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K202688. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AFS Medical Sterile Single-Use Access Port System?
AFS Medical Sterile Single-Use Access Port System is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Afs Medical Co. , Ltd.. The 510(k) number is K202688.
When did AFS Medical Sterile Single-Use Access Port System receive FDA 510(k) clearance?
AFS Medical Sterile Single-Use Access Port System received FDA 510(k) clearance on 2021-10-14, under 510(k) number K202688.
Who is the listed applicant for AFS Medical Sterile Single-Use Access Port System?
The FDA 510(k) record lists Afs Medical Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AFS Medical Sterile Single-Use Access Port System?
The FDA product code for AFS Medical Sterile Single-Use Access Port System is OTJ.
相關臨床試驗
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相關器械（代碼：OTJ）
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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