Ambu Duodeno System
K 號：K201098 · 2020-07-17
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器材摘要
Ambu Duodeno System is the device name listed in this FDA 510(k) record. The listed applicant is Ambu Innovation GmbH. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K201098. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ambu Duodeno System?
Ambu Duodeno System is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Ambu Innovation GmbH. The 510(k) number is K201098.
When did Ambu Duodeno System receive FDA 510(k) clearance?
Ambu Duodeno System received FDA 510(k) clearance on 2020-07-17, under 510(k) number K201098.
Who is the listed applicant for Ambu Duodeno System?
The FDA 510(k) record lists Ambu Innovation GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ambu Duodeno System?
The FDA product code for Ambu Duodeno System is FDT.
相關臨床試驗
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相關器械（代碼：FDT）
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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