BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IRHYTHM TECHNOLOGIES, INC.

    Reg #: 3007208829 · FEI: 3007208829 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    IRHYTHM TECHNOLOGIES, INC.
    Registration Number
    3007208829
    FEI Number
    3007208829
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    699 8th Street, Suite 600
    City
    San Francisco
    State
    CA
    ZIP
    94103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213409

    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
    Computer, Diagnostic, Programmable DQK
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Recorder, Magnetic Tape, Medical DSH
    Detector And Alarm, Arrhythmia DSI
    Outpatient Cardiac Telemetry QYX

    Proprietary Names

    ZEUS Athena System Zio® XT Patch Zio® XT Patch CE Zio ECG Utilization Software (ZEUS) System Zio monitor device Zio ECG Utilization Service (ZEUS) System Zio® AT Patch ZEUS System Zio® AT Gateway Zio AT device Zio Monitor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility