510(k) K053193 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, May 18, 2006 |
| Received | Nov 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053193
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.