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FDA 510(k)

EIDON FA, EIDON, EIDON AF, EIDON UWFL

K-Number: K211328 · 2021-08-19

ApplicantCentervue S.P.A.
Decision Date2021-08-19
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EIDON FA, EIDON, EIDON AF, EIDON UWFL is the device name listed in this FDA 510(k) record. The listed applicant is Centervue S.P.A.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) 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. The listed applicant is Centervue S.P.A.. The 510(k) number is K211328.

When did EIDON FA, EIDON, EIDON AF, EIDON UWFL receive FDA 510(k) clearance?

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

Who is the listed applicant for EIDON FA, EIDON, EIDON AF, EIDON UWFL?

The FDA 510(k) record lists Centervue S.P.A. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Centervue S.P.A. 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.

K243504MAIA (AHMACME001)K234076iCare ALTIUS CWK213705DRSplusK192113DRSplusK180526EIDON FAK180293Retia 2

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Related Devices (Code: MYC)

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.

K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.K243504MAIA (AHMACME001)Centervue S.P.A.K213705DRSplusCentervue S.P.A.K192113DRSplusCentervue S.P.A.K180526EIDON FACentervue S.P.A.K180293Retia 2Centervue 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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