510(k) K252840 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
M12 Telemetry System
| Applicant | Global Instrumentation, LLC, East Syracuse NY, US |
| Decision | Substantially Equivalent, May 29, 2026 |
| Received | Sep 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252840
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.