510(k) K213799 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
N Series Patient Monitors
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 12, 2022 |
| Received | Dec 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213799
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2026 | Mindray DS USA, Inc. BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22. Open, Classified |
MHX | None listed |
| Sep 25, 2025 | Mindray DS USA, Inc. dba Mindray North America BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.