510(k) K251293 ยท QUO Adjunctive Heart Failure Status Indicator
CardioVision
| Applicant | Icardio.Ai, West Hollywood CA, US |
| Decision | Substantially Equivalent, Nov 21, 2025 |
| Received | Apr 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251293
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.