BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DETECTOR AND ALARM, ARRHYTHMIAOutpatient Cardiac Telemetry

    Reg #: 2024089 · FEI: 2024089 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ACS Diagnostics, INC.
    Registration Number
    2024089
    FEI Number
    2024089
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Hughes
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103706

    Owner / Operator

    Firm Name
    Applied Cardiac Systems, Inc.
    Operator Number
    2024089
    Address
    1 Hughes, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    LOREN A MANERA

    Products

    Device Name Product Code
    Outpatient Cardiac Telemetry QYX
    Detector And Alarm, Arrhythmia DSI

    Proprietary Names

    DETECTOR AND ALARM, ARRHYTHMIAOutpatient Cardiac Telemetry

    Establishment Types

    Manufacture Medical Device