510(k) K231424 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
HeartBeam AIMIGo(TM) System
| Applicant | Heartbeam, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Dec 13, 2024 |
| Received | May 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231424
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.