510(k) K230265 · DSI Detector And Alarm, Arrhythmia
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
| Applicant | Infobionic, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Oct 6, 2023 |
| Received | Jan 31, 2023 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K230265
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.