510(k) K241728

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 by Murata Vios, Inc. — Product Code DXN

K241728 is an FDA 510(k) premarket notification submitted by Murata Vios, Inc. for the device "Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050". The FDA issued a decision of Substantially Equivalent on January 23, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Murata Vios, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2025
Date Received
June 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type