510(k) K143195 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-Meidcal Electronics Co., Ltd., Shenzhen, TW |
| Decision | Substantially Equivalent, Dec 22, 2014 |
| Received | Nov 6, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143195
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2016 | Mindray DS USA, Inc. dba Mindray North America Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12 Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.