BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zio ECG Utilization Software (ZEUS) System

    Reg #: 3007208829 · FEI: 3007208829 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    IRHYTHM TECHNOLOGIES, INC.
    Registration Number
    3007208829
    FEI Number
    3007208829
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    699 8th Street, Suite 600
    City
    San Francisco
    State
    CA
    ZIP
    94103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202527

    Owner / Operator

    Firm Name
    iRhythm Technologies, Inc.
    Operator Number
    10026250
    Address
    699 8th St, Suite 600
    City
    San Francisco
    State
    CA
    Postal Code
    94103
    Country
    US
    Correspondent
    Chanda Owens

    Products

    Device Name Product Code
    Detector And Alarm, Arrhythmia DSI
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    Zio ECG Utilization Software (ZEUS) System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility