FDA 510(k)

INSPIRA ART100

Número K: K232788 · 2024-05-24

RequerenteInspira Technologies Oxy B.H.N. , Ltd.

Data da decisão2024-05-24

Código do produtoDWA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

INSPIRA ART100 is the device name listed in this FDA 510(k) record. The listed applicant is Inspira Technologies Oxy B.H.N. , Ltd.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K232788. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the INSPIRA ART100?

INSPIRA ART100 is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Inspira Technologies Oxy B.H.N. , Ltd.. The 510(k) number is K232788.

When did INSPIRA ART100 receive FDA 510(k) clearance?

INSPIRA ART100 received FDA 510(k) clearance on 2024-05-24, under 510(k) number K232788.

Who is the listed applicant for INSPIRA ART100?

The FDA 510(k) record lists Inspira Technologies Oxy B.H.N. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSPIRA ART100?

The FDA product code for INSPIRA ART100 is DWA.

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