510(k) K251508 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Telemetry Monitor (iT30, iT50)
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 6, 2026 |
| Received | May 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251508
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.