Yxoss CBR®
K 號:K192747 · 2020-06-17
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器材摘要
Yxoss CBR® is the device name listed in this FDA 510(k) record. The listed applicant is Reoss GmbH. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K192747. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Yxoss CBR®?
Yxoss CBR® is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Reoss GmbH. The 510(k) number is K192747.
When did Yxoss CBR® receive FDA 510(k) clearance?
Yxoss CBR® received FDA 510(k) clearance on 2020-06-17, under 510(k) number K192747.
Who is the listed applicant for Yxoss CBR®?
The FDA 510(k) record lists Reoss GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Yxoss CBR®?
The FDA product code for Yxoss CBR® is JEY.
相關臨床試驗
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相關器械(代碼:JEY)
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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