FDA 510(k)

Finger Pulse Oximeter

Número K: K163135 · 2017-09-19

RequerenteShenzhen Fitfaith Technology Co.,Ltd

Data da decisão2017-09-19

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Finger Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Fitfaith Technology Co.,Ltd. It received FDA 510(k) clearance on 2017-09-19 under 510(k) number K163135. 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 Pulse Oximeter?

Finger Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Shenzhen Fitfaith Technology Co.,Ltd. The 510(k) number is K163135.

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

Finger Pulse Oximeter received FDA 510(k) clearance on 2017-09-19, under 510(k) number K163135.

Who is the listed applicant for Finger Pulse Oximeter?

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

What is the FDA product code for Finger Pulse Oximeter?

The FDA product code for Finger Pulse Oximeter is DQA.

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Dispositivos Relacionados (Código: DQA)

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