510(k) K220058 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, Jun 1, 2022 |
| Received | Jan 6, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220058
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2025 | Mindray DS USA, Inc. dba Mindray North America Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Open, Classified |
MSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.