SmartBag (智慧包)
K 號：K181643 · 2018-11-16
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器材摘要
SmartBag (SmartPouch) is the device name listed in this FDA 510(k) record. The listed applicant is 11 Health Technologies Limited. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K181643. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SmartBag (SmartPouch)?
SmartBag (SmartPouch) is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is 11 Health Technologies Limited. The 510(k) number is K181643.
When did SmartBag (SmartPouch) receive FDA 510(k) clearance?
SmartBag (SmartPouch) received FDA 510(k) clearance on 2018-11-16, under 510(k) number K181643.
Who is the listed applicant for SmartBag (SmartPouch)?
The FDA 510(k) record lists 11 Health Technologies Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartBag (SmartPouch)?
The FDA product code for SmartBag (SmartPouch) is EXB.
相關臨床試驗
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相關器械（代碼：EXB）
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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