FDA 510(k)

YUWELL Finger Pulse Oximeter

Número K: K212385 · 2022-08-16

RequerenteJiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Data da decisão2022-08-16

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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?

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?

The FDA product code for YUWELL Finger Pulse Oximeter 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)K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)K242736Portable Oxygen Concentrator (Spirit-3)K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

Ver todos os 13 dispositivos →

Dispositivos Relacionados (Código: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Oxímetro de Pulso (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Fonte oficial

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