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FDA 510(k)

c-med0 alpha

K-Number: K253436 · 2026-04-30

ApplicantCosinuss GmbH
Decision Date2026-04-30
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

c-med0 alpha is a medical device manufactured by Cosinuss GmbH. It received FDA 510(k) clearance on 2026-04-30 under approval number K253436. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the c-med0 alpha?

c-med0 alpha is a medical device that received FDA 510(k) clearance on 2026-04-30. It is manufactured by Cosinuss GmbH. The 510(k) number is K253436.

When was c-med0 alpha approved by the FDA?

c-med0 alpha received FDA 510(k) clearance on 2026-04-30, under approval number K253436.

What company makes c-med0 alpha?

c-med0 alpha is manufactured by Cosinuss GmbH.

What is the FDA product code for c-med0 alpha?

The FDA product code for c-med0 alpha is MWI.

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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