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FDA 510(k)

Veuron-Brain-pAb3

K-Number: K231642 · 2023-10-13

ApplicantHeuron Co., Ltd.
Decision Date2023-10-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Veuron-Brain-pAb3 is a medical device manufactured by Heuron Co., Ltd.. It received FDA 510(k) clearance on 2023-10-13 under approval number K231642. 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-pAb3?

Veuron-Brain-pAb3 is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Heuron Co., Ltd.. The 510(k) number is K231642.

When was Veuron-Brain-pAb3 approved by the FDA?

Veuron-Brain-pAb3 received FDA 510(k) clearance on 2023-10-13, under approval number K231642.

What company makes Veuron-Brain-pAb3?

Veuron-Brain-pAb3 is manufactured by Heuron Co., Ltd..

What is the FDA product code for Veuron-Brain-pAb3?

The FDA product code for Veuron-Brain-pAb3 is LLZ.

Other Devices by Heuron Co., Ltd.

K203142Veuron-Brain-pAb K203279Veuron-Brain-mN1 K213801Veuron-Brain-pAb2 K233247Heuron ICH

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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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