Clearance Summary
INSPIRA ART100 received FDA 510(k) clearance under submission number K232788, sponsored by Inspira Technologies Oxy B.H.N. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-05-24.
- Submission: K232788
- Applicant / Sponsor: Inspira Technologies Oxy B.H.N. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4380
- Decision date: 2024-05-24
Classification & Regulation
This clearance is catalogued under FDA product code DWA and 21 CFR 870.4380, within the Cardiovascular review panel as a Class II device.