FDA 510(k)

Disposable SpO2 Sensor

Número K: K192608 · 2020-01-24

RequerenteShenzhen Sino-K Medical Technology Co.,Ltd

Data da decisão2020-01-24

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable SpO2 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2020-01-24 under 510(k) number K192608. 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 Disposable SpO2 Sensor?

Disposable SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. The 510(k) number is K192608.

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

Disposable SpO2 Sensor received FDA 510(k) clearance on 2020-01-24, under 510(k) number K192608.

Who is the listed applicant for Disposable SpO2 Sensor?

The FDA 510(k) record lists Shenzhen Sino-K Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable SpO2 Sensor?

The FDA product code for Disposable SpO2 Sensor is DQA.

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Outros registros que listam Shenzhen Sino-K Medical Technology Co.,Ltd como candidato(a)

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Dispositivos Relacionados (Código: DQA)

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Fonte oficial

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