MyPlant II 偽裝系統
K 號：K173819 · 2018-08-09
廣告
器材摘要
MyPlant II Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Hager& Meisinger GmbH. It received FDA 510(k) clearance on 2018-08-09 under 510(k) number K173819. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MyPlant II Implant System?
MyPlant II Implant System is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K173819.
When did MyPlant II Implant System receive FDA 510(k) clearance?
MyPlant II Implant System received FDA 510(k) clearance on 2018-08-09, under 510(k) number K173819.
Who is the listed applicant for MyPlant II Implant System?
The FDA 510(k) record lists Hager& Meisinger GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MyPlant II Implant System?
The FDA product code for MyPlant II Implant System is DZE.
相關臨床試驗
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其他以 Hager& Meisinger GmbH 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：DZE）
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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