BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RX-1 mini Rhythm Express Remote Cardiac Monitoring System

    Reg #: 3011937459 · FEI: 3011937459 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    VivaQuant
    Registration Number
    3011937459
    FEI Number
    3011937459
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1265 Grey Fox Rd, Suite 400
    City
    Arden Hills
    State
    MN
    ZIP
    55112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200833

    Owner / Operator

    Firm Name
    VivaQuant, Inc
    Operator Number
    10059945
    Address
    1265 Grey Fox Rd, Suite 400
    City
    Arden Hills
    State
    MN
    Postal Code
    55112
    Country
    US
    Correspondent
    Brian Brockway

    Products

    Device Name Product Code
    Detector And Alarm, Arrhythmia DSI
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO

    Proprietary Names

    RX-1 mini Rhythm Express Remote Cardiac Monitoring System

    Establishment Types

    Manufacture Medical Device