510(k) K190011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 10, 2019 |
| Received | Jan 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190011
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2026 | Mindray DS USA, Inc. Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V Open, Classified |
MHX | None listed |
| Oct 7, 2026 | Mindray DS USA, Inc. T1 Patient Monitor. Operator's Manual: T1 Patient Monitor Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.