Xtractor 裝置
K 號：K211679 · 2022-02-17
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器材摘要
Xtractor device is the device name listed in this FDA 510(k) record. The listed applicant is Xcardia Innovation , Ltd.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K211679. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Xtractor device?
Xtractor device is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Xcardia Innovation , Ltd.. The 510(k) number is K211679.
When did Xtractor device receive FDA 510(k) clearance?
Xtractor device received FDA 510(k) clearance on 2022-02-17, under 510(k) number K211679.
Who is the listed applicant for Xtractor device?
The FDA 510(k) record lists Xcardia Innovation , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Xtractor device?
The FDA product code for Xtractor device is DRE.
相關臨床試驗
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相關器械（代碼：DRE）
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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