FDA 510(k)

Sinobot X1

Número K: K220072 · 2023-06-18

RequerenteSinovation (Beijing) Medical Technology Co., Ltd.

Data da decisão2023-06-18

Código do produtoHAW

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sinobot X1 is the device name listed in this FDA 510(k) record. The listed applicant is Sinovation (Beijing) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-18 under 510(k) number K220072. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sinobot X1?

Sinobot X1 is a medical device that received FDA 510(k) clearance on 2023-06-18. The listed applicant is Sinovation (Beijing) Medical Technology Co., Ltd.. The 510(k) number is K220072.

When did Sinobot X1 receive FDA 510(k) clearance?

Sinobot X1 received FDA 510(k) clearance on 2023-06-18, under 510(k) number K220072.

Who is the listed applicant for Sinobot X1?

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

What is the FDA product code for Sinobot X1?

The FDA product code for Sinobot X1 is HAW.

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