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FDA 510(k)

Heuron ICH

K-Number: K233247 · 2024-05-15

ApplicantHeuron Co., Ltd.
Decision Date2024-05-15
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Heuron ICH is a medical device manufactured by Heuron Co., Ltd.. It received FDA 510(k) clearance on 2024-05-15 under approval number K233247. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Heuron ICH?

Heuron ICH is a medical device that received FDA 510(k) clearance on 2024-05-15. It is manufactured by Heuron Co., Ltd.. The 510(k) number is K233247.

When was Heuron ICH approved by the FDA?

Heuron ICH received FDA 510(k) clearance on 2024-05-15, under approval number K233247.

What company makes Heuron ICH?

Heuron ICH is manufactured by Heuron Co., Ltd..

What is the FDA product code for Heuron ICH?

The FDA product code for Heuron ICH is QAS.

Other Devices by Heuron Co., Ltd.

K203142Veuron-Brain-pAb K203279Veuron-Brain-mN1 K213801Veuron-Brain-pAb2 K231642Veuron-Brain-pAb3

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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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