510(k) K250179 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 29, 2025 |
| Received | Jan 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250179
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.