510(k) K260005 ยท DPS Electrocardiograph
MyoVista wavECG (DG-200-B15-003)
| Applicant | HeartSciences, Inc., Southlake TX, US |
| Decision | Substantially Equivalent, Oct 5, 2026 |
| Received | Jan 2, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260005
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.