HANAROSTENT 食道非對稱式 (CCC)
K 號：K213251 · 2021-11-18
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器材摘要
HANAROSTENT Esophagus Asymmetric (CCC) is the device name listed in this FDA 510(k) record. The listed applicant is M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K213251. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the HANAROSTENT Esophagus Asymmetric (CCC)?
HANAROSTENT Esophagus Asymmetric (CCC) is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K213251.
When did HANAROSTENT Esophagus Asymmetric (CCC) receive FDA 510(k) clearance?
HANAROSTENT Esophagus Asymmetric (CCC) received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213251.
Who is the listed applicant for HANAROSTENT Esophagus Asymmetric (CCC)?
The FDA 510(k) record lists M.I.Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HANAROSTENT Esophagus Asymmetric (CCC)?
The FDA product code for HANAROSTENT Esophagus Asymmetric (CCC) is ESW.
相關臨床試驗
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。
其他以 M.I.Tech Co., Ltd. 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：ESW）
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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