FDA 510(k)

IVX Fluid Transfer Set

K-Number: K212530 · 2022-04-24

Decision Date2022-04-24

Product CodeLHI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

IVX Fluid Transfer Set is a medical device manufactured by Omnicell, Inc.. It received FDA 510(k) clearance on 2022-04-24 under approval number K212530. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVX Fluid Transfer Set?

IVX Fluid Transfer Set is a medical device that received FDA 510(k) clearance on 2022-04-24. It is manufactured by Omnicell, Inc.. The 510(k) number is K212530.

When was IVX Fluid Transfer Set approved by the FDA?

IVX Fluid Transfer Set received FDA 510(k) clearance on 2022-04-24, under approval number K212530.

What company makes IVX Fluid Transfer Set?

IVX Fluid Transfer Set is manufactured by Omnicell, Inc..

What is the FDA product code for IVX Fluid Transfer Set?

The FDA product code for IVX Fluid Transfer Set is LHI.

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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.