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FDA 510(k)

EIDON FA, EIDON, EIDON AF, EIDON UWFL

K-Number: K211328 · 2021-08-19

Decision Date2021-08-19
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EIDON FA, EIDON, EIDON AF, EIDON UWFL is a medical device manufactured by Centervue S.P.A.. It received FDA 510(k) clearance on 2021-08-19 under approval number K211328. 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 EIDON FA, EIDON, EIDON AF, EIDON UWFL?

EIDON FA, EIDON, EIDON AF, EIDON UWFL is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by Centervue S.P.A.. The 510(k) number is K211328.

When was EIDON FA, EIDON, EIDON AF, EIDON UWFL approved by the FDA?

EIDON FA, EIDON, EIDON AF, EIDON UWFL received FDA 510(k) clearance on 2021-08-19, under approval number K211328.

What company makes EIDON FA, EIDON, EIDON AF, EIDON UWFL?

EIDON FA, EIDON, EIDON AF, EIDON UWFL is manufactured by Centervue S.P.A..

What is the FDA product code for EIDON FA, EIDON, EIDON AF, EIDON UWFL?

The FDA product code for EIDON FA, EIDON, EIDON AF, EIDON UWFL is MYC.

Other Devices by Centervue S.P.A.

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Related Devices (Code: MYC)

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.