BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050

    K Number: K241728 · Decision Jan 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    223

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
    K Number
    K241728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Murata Vios, Inc.
    Date Received
    June 14, 2024
    Decision Date
    January 23, 2025
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.

    Wrist Blood Pressure Monitor (XW-05)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VicorderCS (VCS-SYS-1100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Upper arm electronic blood pressure monitor (XB-01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blood Pressure Monitor (W06LT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Murata Vios, Inc.

    K Number Device Name
    K232354 Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software