Clearance Summary
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 received FDA 510(k) clearance under submission number K241728, sponsored by Murata Vios, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-01-23.
- Submission: K241728
- Applicant / Sponsor: Murata Vios, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2025-01-23
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.