FDA 510(k)

Veuron-Brain-pAb

K-Number: K203142 · 2021-01-15

Decision Date2021-01-15

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Veuron-Brain-pAb is the device name listed in this FDA 510(k) record. The listed applicant is Heuron Co., Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203142. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Veuron-Brain-pAb?

Veuron-Brain-pAb is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Heuron Co., Ltd.. The 510(k) number is K203142.

When did Veuron-Brain-pAb receive FDA 510(k) clearance?

Veuron-Brain-pAb received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203142.

Who is the listed applicant for Veuron-Brain-pAb?

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

What is the FDA product code for Veuron-Brain-pAb?

The FDA product code for Veuron-Brain-pAb is LLZ.

Other records listing Heuron 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.

K233247Heuron ICH K231642Veuron-Brain-pAb3 K203279Veuron-Brain-mN1 K213801Veuron-Brain-pAb2

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Official Source

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