510(k) K262839 ยท QXZ Adjunctive Epicardial Vascular Physiologic Status Indicator
Cleerly ISCHEMIA
| Applicant | Cleerly, Inc., Denver CO, US |
| Decision | Substantially Equivalent, Oct 29, 2026 |
| Received | Aug 11, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K262839
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.