510(k) K250356 · DSI Detector And Alarm, Arrhythmia
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
| Applicant | Infobionic, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Jul 29, 2025 |
| Received | Feb 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250356
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.