FDA 510(k)

YUWELL®手指血氧計（YX105、YX106、YX110、YX310）

K 號：K252805 · 2026-02-17

申請人Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

決定日期2026-02-17

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) 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 2026-02-17 under 510(k) number K252805. 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 (YX105, YX106, YX110, YX310)?

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) is a medical device that received FDA 510(k) clearance on 2026-02-17. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K252805.

When did YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) receive FDA 510(k) clearance?

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) received FDA 510(k) clearance on 2026-02-17, under 510(k) number K252805.

Who is the listed applicant for YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)?

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 (YX105, YX106, YX110, YX310)?

The FDA product code for YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) is DQA.

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。

K261571手動輪椅（H008，PCK7）K252779宇威®電子血壓計（YE630CR）K253228YUWELL® 電子血壓計 (YE650AR)K242736攜帶式氧氣濃縮器（Spirit-3）K250878YUWELL® 紅外線耳溫計（YHT100）；YUWELL® 紅外線耳溫計（YHT107）K213825氧濃度濃縮機型號 8F-3A，氧濃度濃縮機型號 8F-5A

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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

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