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Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories4
Latest Approval2026-03-05
TypeNumberDevice NameCodeDate
510(k) K252779 YUWELL® Electronic Blood Pressure Monitor (YE630CR) DXN 2026-03-05 View
510(k) K253228 YUWELL® Electronic Blood Pressure Monitor (YE650AR) DXN 2026-02-23 View
510(k) K252805 YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) DQA 2026-02-17 View
510(k) K242736 Portable Oxygen Concentrator (Spirit-3) CAW 2025-06-05 View
510(k) K250878 YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) FLL 2025-05-22 View
510(k) K213825 Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A CAW 2023-04-28 View
510(k) K221372 YUWELL Electronic Blood Pressure Monitor DXN 2022-10-17 View
510(k) K212385 YUWELL Finger Pulse Oximeter DQA 2022-08-16 View
510(k) K203583 YUWELL infrared ear thermometer: YHT101, YHT200 FLL 2021-05-20 View
510(k) K201864 YUWELL Infrared Thermometer FLL 2020-12-07 View
510(k) K200939 Electronic Blood Pressure Monitor DXN 2020-08-20 View
510(k) K170605 Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D DXN 2018-03-27 View