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FDA 510(k)

Sinobot X1

K-Number: K220072 · 2023-06-18

ApplicantSinovation (Beijing) Medical Technology Co., Ltd.
Decision Date2023-06-18
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Sinobot X1?

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

When was Sinobot X1 approved by the FDA?

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

What company makes Sinobot X1?

Sinobot X1 is manufactured by Sinovation (Beijing) Medical Technology Co., Ltd..

What is the FDA product code for Sinobot X1?

The FDA product code for Sinobot X1 is HAW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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