510(k) K162607 ยท MSX System, Network And Communication, Physiological Monitors
BeneVision Central Monitoring System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 20, 2017 |
| Received | Sep 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2018 | Mindray DS USA, Inc. dba Mindray North America Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.