FDA 510(k)

Veuron-Brain-pAb2

K-Number: K213801 · 2022-02-04

Decision Date2022-02-04

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Veuron-Brain-pAb2 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 2022-02-04 under 510(k) number K213801. 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-pAb2?

Veuron-Brain-pAb2 is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Heuron Co., Ltd.. The 510(k) number is K213801.

When did Veuron-Brain-pAb2 receive FDA 510(k) clearance?

Veuron-Brain-pAb2 received FDA 510(k) clearance on 2022-02-04, under 510(k) number K213801.

Who is the listed applicant for Veuron-Brain-pAb2?

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-pAb2?

The FDA product code for Veuron-Brain-pAb2 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 K203142Veuron-Brain-pAb

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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.