旭化成ViE-U系列透析器
K 號：K162248 · 2017-05-03
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器材摘要
Asahi ViE-U Series Dialyzer is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Kasei Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K162248. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Asahi ViE-U Series Dialyzer?
Asahi ViE-U Series Dialyzer is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Asahi Kasei Medical Co., Ltd.. The 510(k) number is K162248.
When did Asahi ViE-U Series Dialyzer receive FDA 510(k) clearance?
Asahi ViE-U Series Dialyzer received FDA 510(k) clearance on 2017-05-03, under 510(k) number K162248.
Who is the listed applicant for Asahi ViE-U Series Dialyzer?
The FDA 510(k) record lists Asahi Kasei Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Asahi ViE-U Series Dialyzer?
The FDA product code for Asahi ViE-U Series Dialyzer is KDI.
相關臨床試驗
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相關器械（代碼：KDI）
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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