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FDA 510(k)

Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)

N.º K: K212665 · 2022-06-22

SolicitanteHuizhou Xiaoou Technology Co., Ltd.
Fecha de decisión2022-06-22
Código de productoDQA
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Xiaoou Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K212665. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)?

Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Huizhou Xiaoou Technology Co., Ltd.. The 510(k) number is K212665.

When did Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) receive FDA 510(k) clearance?

Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) received FDA 510(k) clearance on 2022-06-22, under 510(k) number K212665.

Who is the listed applicant for Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)?

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

What is the FDA product code for Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)?

The FDA product code for Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) is DQA.

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Dispositivos relacionados (Código: DQA)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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