510(k) K150082 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Panorama Patient Monitoring Network
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 2, 2015 |
| Received | Jan 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2016 | Mindray DS USA, Inc. dba Mindray North America Panorama Patient Monitoring Network.
Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910.
The Pa Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.