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FDA 510(k)

CerebralGo Plus

K-Number: K213986 · 2023-04-13

Decision Date2023-04-13
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CerebralGo Plus is the device name listed in this FDA 510(k) record. The listed applicant is Yukun (Beijing) Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K213986. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CerebralGo Plus?

CerebralGo Plus is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Yukun (Beijing) Technology Co., Ltd.. The 510(k) number is K213986.

When did CerebralGo Plus receive FDA 510(k) clearance?

CerebralGo Plus received FDA 510(k) clearance on 2023-04-13, under 510(k) number K213986.

Who is the listed applicant for CerebralGo Plus?

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

What is the FDA product code for CerebralGo Plus?

The FDA product code for CerebralGo Plus is QIH.

Other records listing Yukun (Beijing) Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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