510(k) K172586 · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Vios Monitoring System Model 2050
| Applicant | Vios Medical, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jun 22, 2018 |
| Received | Aug 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2025 | Murata Vios, Inc. Vios Monitoring System Bedside Monitor Model BSM2050 Open, Classified |
DRT | None listed |
| Feb 12, 2025 | Murata Vios, Inc. Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00 Open, Classified |
DRT | None listed |
| Jan 30, 2025 | Murata Vios, Inc. muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate Open, Classified |
DRT | None listed |
| Jan 16, 2025 | Murata Vios, Inc. muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate Completed |
DRT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.