510(k) K250854 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
| Applicant | Shenzhen Comen Medical Instruments Co.,Ltd, Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 17, 2025 |
| Received | Mar 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250854
No recall in the FDA data names this 510(k).
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