YSIO X.pree 医療設備規範文本翻譯： YSIO X.pree 医療設備規範文本
K 號：K233543 · 2024-05-21
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器材摘要
YSIO X.pree is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions. It received FDA 510(k) clearance on 2024-05-21 under 510(k) number K233543. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the YSIO X.pree?
YSIO X.pree is a medical device that received FDA 510(k) clearance on 2024-05-21. The listed applicant is Siemens Medical Solutions. The 510(k) number is K233543.
When did YSIO X.pree receive FDA 510(k) clearance?
YSIO X.pree received FDA 510(k) clearance on 2024-05-21, under 510(k) number K233543.
Who is the listed applicant for YSIO X.pree?
The FDA 510(k) record lists Siemens Medical Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for YSIO X.pree?
The FDA product code for YSIO X.pree is KPR.
其他以 Siemens Medical Solutions 為申請人之記錄
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相關器械（代碼：KPR）
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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