510(k) K193391 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, May 21, 2020 |
| Received | Dec 6, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193391
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2021 | Mindray DS USA, Inc. dba Mindray North America 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with Terminated |
MSX | None listed |
| Feb 22, 2021 | Mindray DS USA, Inc. dba Mindray North America Mindray BeneVision Distributed Monitoring System( DMS)
1. p/n 115-051209-00
2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions:
03.04.00
04.01.00
04.03.00
04.04.00
0 Open, Classified |
MSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.