510(k) K253170 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 16, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253170
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.