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FDA 510(k)

MAIA

K-Number: K153181 · 2016-06-08

ApplicantCentervue S.P.A.
Decision Date2016-06-08
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAIA is a medical device manufactured by Centervue S.P.A.. It received FDA 510(k) clearance on 2016-06-08 under approval number K153181. 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?

MAIA is a medical device that received FDA 510(k) clearance on 2016-06-08. It is manufactured by Centervue S.P.A.. The 510(k) number is K153181.

When was MAIA approved by the FDA?

MAIA received FDA 510(k) clearance on 2016-06-08, under approval number K153181.

What company makes MAIA?

MAIA is manufactured by Centervue S.P.A..

What is the FDA product code for MAIA?

The FDA product code for MAIA is MYC.

Other Devices by Centervue S.P.A.

K180526EIDON FA K180293Retia 2 K192113DRSplus K213705DRSplus K211328EIDON FA, EIDON, EIDON AF, EIDON UWFL K234076iCare ALTIUS CW

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Related Devices (Code: MYC)

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. K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.

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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