iSurg
K 號：K170054 · 2017-10-02
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決定日期2017-10-02
產品代碼GEI
諮詢委員會SU
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決定相當於
器材摘要
iSurg is the device name listed in this FDA 510(k) record. The listed applicant is Jaco, LLC Dba Macan Manufacturing and Bna Burz North America. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K170054. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the iSurg?
iSurg is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Jaco, LLC Dba Macan Manufacturing and Bna Burz North America. The 510(k) number is K170054.
When did iSurg receive FDA 510(k) clearance?
iSurg received FDA 510(k) clearance on 2017-10-02, under 510(k) number K170054.
Who is the listed applicant for iSurg?
The FDA 510(k) record lists Jaco, LLC Dba Macan Manufacturing and Bna Burz North America as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iSurg?
The FDA product code for iSurg is GEI.
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。
相關器械（代碼：GEI）
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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