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FDA 510(k)

AeviceMD

K-Number: K243603 · 2025-05-05

ApplicantAevice Health Pte. , Ltd.
Decision Date2025-05-05
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AeviceMD is a medical device manufactured by Aevice Health Pte. , Ltd.. It received FDA 510(k) clearance on 2025-05-05 under approval number K243603. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AeviceMD?

AeviceMD is a medical device that received FDA 510(k) clearance on 2025-05-05. It is manufactured by Aevice Health Pte. , Ltd.. The 510(k) number is K243603.

When was AeviceMD approved by the FDA?

AeviceMD received FDA 510(k) clearance on 2025-05-05, under approval number K243603.

What company makes AeviceMD?

AeviceMD is manufactured by Aevice Health Pte. , Ltd..

What is the FDA product code for AeviceMD?

The FDA product code for AeviceMD is DSH.

Other Devices by Aevice Health Pte. , Ltd.

K223382AeviceMD

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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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