FDA 510(k)

SpO2 Sensor

Número K: K183277 · 2019-05-15

RequerenteShenzhen Upnmed Equipment Co., Ltd.

Data da decisão2019-05-15

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SpO2 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Upnmed Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K183277. 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 SpO2 Sensor?

SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is Shenzhen Upnmed Equipment Co., Ltd.. The 510(k) number is K183277.

When did SpO2 Sensor receive FDA 510(k) clearance?

SpO2 Sensor received FDA 510(k) clearance on 2019-05-15, under 510(k) number K183277.

Who is the listed applicant for SpO2 Sensor?

The FDA 510(k) record lists Shenzhen Upnmed Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpO2 Sensor?

The FDA product code for SpO2 Sensor is DQA.

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Dispositivos Relacionados (Código: DQA)

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