510(k) K043348 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MODIFICATION TO PM-8000 PATIENT MONITOR
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Jan 6, 2005 |
| Received | Dec 6, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043348
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.