FDA 510(k)

ZIEN IO Intraosseous Access System

Número K: K240915 · 2024-07-02

RequerenteZien Medical Technologies, Inc.

Data da decisão2024-07-02

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ZIEN IO Intraosseous Access System is the device name listed in this FDA 510(k) record. The listed applicant is Zien Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-07-02 under 510(k) number K240915. 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 ZIEN IO Intraosseous Access System?

ZIEN IO Intraosseous Access System is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Zien Medical Technologies, Inc.. The 510(k) number is K240915.

When did ZIEN IO Intraosseous Access System receive FDA 510(k) clearance?

ZIEN IO Intraosseous Access System received FDA 510(k) clearance on 2024-07-02, under 510(k) number K240915.

Who is the listed applicant for ZIEN IO Intraosseous Access System?

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

What is the FDA product code for ZIEN IO Intraosseous Access System?

The FDA product code for ZIEN IO Intraosseous Access System is FMI.

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