FDA 510(k)

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

Número K: K252805 · 2026-02-17

RequerenteJiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Data da decisão2026-02-17

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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)?

The FDA 510(k) record lists Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Outros registros que listam Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. como candidato(a)

K261571Manual Wheelchair (H008, PCK7)K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)K242736Portable Oxygen Concentrator (Spirit-3)K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

Ver todos os 13 dispositivos →

Dispositivos Relacionados (Código: DQA)

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Fonte oficial

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