510(k) K080192 ยท MSX System, Network And Communication, Physiological Monitors
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Apr 3, 2008 |
| Received | Jan 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080192
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2013 | Mindray DS USA, Inc. d.b.a. Mindray North America Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgra Terminated |
MSX | None listed |
| Jan 3, 2013 | Mindray DS USA, Inc. d.b.a. Mindray North America DPM Central Station
Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430
The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network dev Terminated |
MSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.