FDA 510(k)

YUWELL® Electronic Blood Pressure Monitor (YE630CR)

N.º K: K252779 · 2026-03-05

SolicitanteJiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Fecha de decisión2026-03-05

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

YUWELL® Electronic Blood Pressure Monitor (YE630CR) 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 2026-03-05 under 510(k) number K252779. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the YUWELL® Electronic Blood Pressure Monitor (YE630CR)?

YUWELL® Electronic Blood Pressure Monitor (YE630CR) is a medical device that received FDA 510(k) clearance on 2026-03-05. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K252779.

When did YUWELL® Electronic Blood Pressure Monitor (YE630CR) receive FDA 510(k) clearance?

YUWELL® Electronic Blood Pressure Monitor (YE630CR) received FDA 510(k) clearance on 2026-03-05, under 510(k) number K252779.

Who is the listed applicant for YUWELL® Electronic Blood Pressure Monitor (YE630CR)?

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® Electronic Blood Pressure Monitor (YE630CR)?

The FDA product code for YUWELL® Electronic Blood Pressure Monitor (YE630CR) is DXN.

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Otros registros que enlistan a Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. como solicitante

K261571Manual Wheelchair (H008, PCK7)K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)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

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Dispositivos relacionados (Código: DXN)

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Fuente oficial

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