FDA 510(k)

Med-link Pulse Oximeter

Número K: K212752 · 2022-05-20

RequerenteShenzhen Med-Link Electronics Tech Co., Ltd.

Data da decisão2022-05-20

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Med-link Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-05-20 under 510(k) number K212752. 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 Med-link Pulse Oximeter?

Med-link Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2022-05-20. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K212752.

When did Med-link Pulse Oximeter receive FDA 510(k) clearance?

Med-link Pulse Oximeter received FDA 510(k) clearance on 2022-05-20, under 510(k) number K212752.

Who is the listed applicant for Med-link Pulse Oximeter?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Med-link Pulse Oximeter?

The FDA product code for Med-link Pulse Oximeter is DQA.

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Dispositivos Relacionados (Código: DQA)

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Fonte oficial

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