FDA 510(k)

IVX Fluid Transfer Set

Número K: K212530 · 2022-04-24

Data da decisão2022-04-24

Código do produtoLHI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Omnicell, Inc.. The 510(k) number is K212530.

When did IVX Fluid Transfer Set receive FDA 510(k) clearance?

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

Who is the listed applicant for IVX Fluid Transfer Set?

The FDA 510(k) record lists Omnicell, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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