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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 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.

Frequently Asked Questions

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.

Related Devices (Code: DWA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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