510(k) K260098 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, May 20, 2026 |
| Received | Jan 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260098
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2026 | Mindray DS USA, Inc. ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.