MI 分離器
K 號：K210006 · 2021-03-04
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器材摘要
MI DeTACH is the device name listed in this FDA 510(k) record. The listed applicant is Biorep Technologies, Inc.. It received FDA 510(k) clearance on 2021-03-04 under 510(k) number K210006. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MI DeTACH?
MI DeTACH is a medical device that received FDA 510(k) clearance on 2021-03-04. The listed applicant is Biorep Technologies, Inc.. The 510(k) number is K210006.
When did MI DeTACH receive FDA 510(k) clearance?
MI DeTACH received FDA 510(k) clearance on 2021-03-04, under 510(k) number K210006.
Who is the listed applicant for MI DeTACH?
The FDA 510(k) record lists Biorep Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MI DeTACH?
The FDA product code for MI DeTACH is DXC.
相關臨床試驗
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相關器械（代碼：DXC）
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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