510(k) K242518 ยท QAQ Adjunctive Predictive Cardiovascular Indicator
Hypertension Prediction Index (HePI) Algorithm
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, May 15, 2025 |
| Received | Aug 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242518
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.