K232354
- 510(k) number
- K232354
- Device name
- Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
- Applicant
- Murata Vios, Inc. MN · US
- Product code
- DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alar
- Decision date
- 2024-03-22
- Date received
- 2023-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232354.pdf
Official FDA record: K232354
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.