Clearance Summary
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software received FDA 510(k) clearance under submission number K232354, 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 2024-03-22.
- Submission: K232354
- Applicant / Sponsor: Murata Vios, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2024-03-22
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.