HANAROCare 再生
K 號：K160893 · 2016-07-27
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器材摘要
HANAROCare ReJu 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 2016-07-27 under 510(k) number K160893. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the HANAROCare ReJu?
HANAROCare ReJu is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K160893.
When did HANAROCare ReJu receive FDA 510(k) clearance?
HANAROCare ReJu received FDA 510(k) clearance on 2016-07-27, under 510(k) number K160893.
Who is the listed applicant for HANAROCare ReJu?
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 HANAROCare ReJu?
The FDA product code for HANAROCare ReJu is NUH.
相關臨床試驗
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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：NUH）
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
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