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FDA 510(k)

Alzevita

K-Number: K252670 · 2025-12-19

ApplicantTOPIA MEDTECH LIMITED
Decision Date2025-12-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Alzevita is a medical device manufactured by TOPIA MEDTECH LIMITED. It received FDA 510(k) clearance on 2025-12-19 under approval number K252670. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alzevita?

Alzevita is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by TOPIA MEDTECH LIMITED. The 510(k) number is K252670.

When was Alzevita approved by the FDA?

Alzevita received FDA 510(k) clearance on 2025-12-19, under approval number K252670.

What company makes Alzevita?

Alzevita is manufactured by TOPIA MEDTECH LIMITED.

What is the FDA product code for Alzevita?

The FDA product code for Alzevita is QIH.

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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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