FDA 510(k)

AeviceMD

K-Number: K243603 · 2025-05-05

Decision Date2025-05-05

Product CodeDSH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AeviceMD is the device name listed in this FDA 510(k) record. The listed applicant is Aevice Health Pte. , Ltd.. It received FDA 510(k) clearance on 2025-05-05 under 510(k) 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. The listed applicant is Aevice Health Pte. , Ltd.. The 510(k) number is K243603.

When did AeviceMD receive FDA 510(k) clearance?

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

Who is the listed applicant for AeviceMD?

The FDA 510(k) record lists Aevice Health Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AeviceMD?

The FDA product code for AeviceMD is DSH.

Other records listing Aevice Health Pte. , 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.

K223382AeviceMD

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.