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FDA 510(k)

Qitexio

K-Number: K203738 · 2022-03-14

ApplicantMedex
Decision Date2022-03-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Qitexio is a medical device manufactured by Medex. It received FDA 510(k) clearance on 2022-03-14 under approval number K203738. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Qitexio?

Qitexio is a medical device that received FDA 510(k) clearance on 2022-03-14. It is manufactured by Medex. The 510(k) number is K203738.

When was Qitexio approved by the FDA?

Qitexio received FDA 510(k) clearance on 2022-03-14, under approval number K203738.

What company makes Qitexio?

Qitexio is manufactured by Medex.

What is the FDA product code for Qitexio?

The FDA product code for Qitexio is FMF.

Other Devices by Medex

Related Devices (Code: FMF)

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.