510(k) K053234 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
PM-9000 EXPRESS PATIENT MONITOR
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, May 4, 2006 |
| Received | Nov 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053234
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2013 | Mindray DS USA, Inc. d.b.a. Mindray North America Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities. Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.