宇威指脈血氧計
K 號：K212385 · 2022-08-16
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器材摘要
YUWELL Finger Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-08-16 under 510(k) number K212385. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the YUWELL Finger Pulse Oximeter?
YUWELL Finger Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2022-08-16. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K212385.
When did YUWELL Finger Pulse Oximeter receive FDA 510(k) clearance?
YUWELL Finger Pulse Oximeter received FDA 510(k) clearance on 2022-08-16, under 510(k) number K212385.
Who is the listed applicant for YUWELL Finger Pulse Oximeter?
FDA 510(k) 記錄將江蘇玉宇醫療設備與供應有限公司列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for YUWELL Finger Pulse Oximeter?
The FDA product code for YUWELL Finger Pulse Oximeter is DQA.
相關臨床試驗
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其他以 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 為申請人之記錄
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：DQA）
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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