510(k) K152902 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, Feb 18, 2016 |
| Received | Oct 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152902
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2017 | Mindray DS USA, Inc. dba Mindray North America TI Transport Monitor/Module Battery Pack
Product Usage:
intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.