Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Veuron-Brain-pAb2

K-Number: K213801 · 2022-02-04

ApplicantHeuron Co., Ltd.
Decision Date2022-02-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Veuron-Brain-pAb2 is a medical device manufactured by Heuron Co., Ltd.. It received FDA 510(k) clearance on 2022-02-04 under approval 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. It is manufactured by Heuron Co., Ltd.. The 510(k) number is K213801.

When was Veuron-Brain-pAb2 approved by the FDA?

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

What company makes Veuron-Brain-pAb2?

Veuron-Brain-pAb2 is manufactured by Heuron Co., Ltd..

What is the FDA product code for Veuron-Brain-pAb2?

The FDA product code for Veuron-Brain-pAb2 is LLZ.

Other Devices by Heuron Co., Ltd.

K203142Veuron-Brain-pAb K203279Veuron-Brain-mN1 K231642Veuron-Brain-pAb3 K233247Heuron ICH

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑