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.
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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.