uMR 680
K 號：K222755 · 2023-02-16
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器材摘要
uMR 680 is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K222755. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the uMR 680?
uMR 680 is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. The 510(k) number is K222755.
When did uMR 680 receive FDA 510(k) clearance?
uMR 680 received FDA 510(k) clearance on 2023-02-16, under 510(k) number K222755.
Who is the listed applicant for uMR 680?
The FDA 510(k) record lists Shanghai United Imaging Intelligence Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for uMR 680?
The FDA product code for uMR 680 is LNH.
其他以 Shanghai United Imaging Intelligence Co., Ltd. 為申請人之記錄
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相關器械（代碼：LNH）
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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