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FDA 510(k)

Veuron-Brain-mN1

K-Number: K203279 · 2022-07-12

ApplicantHeuron Co., Ltd.
Decision Date2022-07-12
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Veuron-Brain-mN1 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 2022-07-12 under 510(k) number K203279. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Veuron-Brain-mN1?

Veuron-Brain-mN1 is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Heuron Co., Ltd.. The 510(k) number is K203279.

When did Veuron-Brain-mN1 receive FDA 510(k) clearance?

Veuron-Brain-mN1 received FDA 510(k) clearance on 2022-07-12, under 510(k) number K203279.

Who is the listed applicant for Veuron-Brain-mN1?

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-mN1?

The FDA product code for Veuron-Brain-mN1 is LNH.

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 ICHK231642Veuron-Brain-pAb3K213801Veuron-Brain-pAb2K203142Veuron-Brain-pAb

Related Devices (Code: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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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