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FDA 510(k)

INSPIRA ART100

K-Number: K232788 · 2024-05-24

ApplicantInspira Technologies Oxy B.H.N. , Ltd.
Decision Date2024-05-24
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the INSPIRA ART100?

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

When was INSPIRA ART100 approved by the FDA?

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

What company makes INSPIRA ART100?

INSPIRA ART100 is manufactured by Inspira Technologies Oxy B.H.N. , Ltd..

What is the FDA product code for INSPIRA ART100?

The FDA product code for INSPIRA ART100 is DWA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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