FDA 510(k)

EZ-IO Intraosseous Vascular Access System

Número K: K231924 · 2023-07-25

Data da decisão2023-07-25

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

EZ-IO Intraosseous Vascular Access System is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K231924. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EZ-IO Intraosseous Vascular Access System?

EZ-IO Intraosseous Vascular Access System is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Teleflex Medical. The 510(k) number is K231924.

When did EZ-IO Intraosseous Vascular Access System receive FDA 510(k) clearance?

EZ-IO Intraosseous Vascular Access System received FDA 510(k) clearance on 2023-07-25, under 510(k) number K231924.

Who is the listed applicant for EZ-IO Intraosseous Vascular Access System?

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

What is the FDA product code for EZ-IO Intraosseous Vascular Access System?

The FDA product code for EZ-IO Intraosseous Vascular Access System is FMI.

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