510(k) K250258 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
HeartBeam AIMIGo with 12-L ECG Synthesis Software System
| Applicant | Heartbeam, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Dec 8, 2025 |
| Received | Jan 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250258
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.