K232788
- 510(k) number
- K232788
- Device name
- INSPIRA ART100
- Applicant
- Inspira Technologies Oxy B.H.N. , Ltd. IL
- Product code
- DWA — Control, Pump Speed, Cardiopulmonary Bypass
- Decision date
- 2024-05-24
- Date received
- 2023-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232788.pdf
Official FDA record: K232788
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.