510(k) K232788 · DWA Control, Pump Speed, Cardiopulmonary Bypass
INSPIRA ART100
| Applicant | Inspira Technologies Oxy B.H.N. , Ltd., RaAnana, IL |
| Decision | Substantially Equivalent, May 24, 2024 |
| Received | Sep 11, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232788
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.