FDA 510(k)

Finger Clip Pulse Oximeter

Número K: K231243 · 2023-10-31

RequerenteGuangdong Genial Technology Co., Ltd.

Data da decisão2023-10-31

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Finger Clip Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Genial Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K231243. 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 Finger Clip Pulse Oximeter?

Finger Clip Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Guangdong Genial Technology Co., Ltd.. The 510(k) number is K231243.

When did Finger Clip Pulse Oximeter receive FDA 510(k) clearance?

Finger Clip Pulse Oximeter received FDA 510(k) clearance on 2023-10-31, under 510(k) number K231243.

Who is the listed applicant for Finger Clip Pulse Oximeter?

The FDA 510(k) record lists Guangdong Genial Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Finger Clip Pulse Oximeter?

The FDA product code for Finger Clip Pulse Oximeter is DQA.

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Outros registros que listam Guangdong Genial Technology Co., Ltd. como candidato(a)

K240333Wearable Digital Thermometer (T31)K232678Digital Thermometer, Model T28, T28L K231250Digital Blood Pressure Monitor K231245Digital Blood Pressure Monitor (Arm Type)

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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