510(k) K242728 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, Jul 31, 2025 |
| Received | Sep 10, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242728
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2026 | Mindray DS USA, Inc. BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80 Open, Classified |
MSX | None listed |
| Oct 7, 2026 | Mindray DS USA, Inc. Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60). Open, Classified |
MSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.