SafeBreak 頸動脈
K 號：K222791 · 2022-10-16
廣告
決定日期2022-10-16
產品代碼QOI
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
SafeBreak Vascular is the device name listed in this FDA 510(k) record. The listed applicant is Lineus Medical, LLC. It received FDA 510(k) clearance on 2022-10-16 under 510(k) number K222791. The device is classified under product code QOI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SafeBreak Vascular?
SafeBreak Vascular is a medical device that received FDA 510(k) clearance on 2022-10-16. The listed applicant is Lineus Medical, LLC. The 510(k) number is K222791.
When did SafeBreak Vascular receive FDA 510(k) clearance?
SafeBreak Vascular received FDA 510(k) clearance on 2022-10-16, under 510(k) number K222791.
Who is the listed applicant for SafeBreak Vascular?
The FDA 510(k) record lists Lineus Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SafeBreak Vascular?
The FDA product code for SafeBreak Vascular is QOI.
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：QOI）
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。
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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