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FDA 510(k)

MAIA (AHMACME001)

K-Number: K243504 · 2025-03-17

ApplicantCentervue S.P.A.
Decision Date2025-03-17
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAIA (AHMACME001) is a medical device manufactured by Centervue S.P.A.. It received FDA 510(k) clearance on 2025-03-17 under approval number K243504. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAIA (AHMACME001)?

MAIA (AHMACME001) is a medical device that received FDA 510(k) clearance on 2025-03-17. It is manufactured by Centervue S.P.A.. The 510(k) number is K243504.

When was MAIA (AHMACME001) approved by the FDA?

MAIA (AHMACME001) received FDA 510(k) clearance on 2025-03-17, under approval number K243504.

What company makes MAIA (AHMACME001)?

MAIA (AHMACME001) is manufactured by Centervue S.P.A..

What is the FDA product code for MAIA (AHMACME001)?

The FDA product code for MAIA (AHMACME001) is MYC.

Other Devices by Centervue S.P.A.

K153181MAIA K180526EIDON FA K180293Retia 2 K192113DRSplus K213705DRSplus K211328EIDON FA, EIDON, EIDON AF, EIDON UWFL

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Related Devices (Code: MYC)

K153181MAIACentervue S.P.A. K180526EIDON FACentervue S.P.A. K180293Retia 2Centervue S.P.A. K192113DRSplusCentervue S.P.A. K213705DRSplusCentervue S.P.A. K211328EIDON FA, EIDON, EIDON AF, EIDON UWFLCentervue S.P.A.

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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