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FDA 510(k)

FONA XDC

K-Number: K222274 · 2022-08-23

ApplicantFona S.R.L
Decision Date2022-08-23
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FONA XDC is a medical device manufactured by Fona S.R.L. It received FDA 510(k) clearance on 2022-08-23 under approval number K222274. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FONA XDC?

FONA XDC is a medical device that received FDA 510(k) clearance on 2022-08-23. It is manufactured by Fona S.R.L. The 510(k) number is K222274.

When was FONA XDC approved by the FDA?

FONA XDC received FDA 510(k) clearance on 2022-08-23, under approval number K222274.

What company makes FONA XDC?

FONA XDC is manufactured by Fona S.R.L.

What is the FDA product code for FONA XDC?

The FDA product code for FONA XDC is EHD.

Other Devices by Fona S.R.L

K161131FONA Pan/Ceph K212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

Related Devices (Code: EHD)

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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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