BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ICON LLC

    Reg #: 3014522540 · FEI: 3014522540 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    ICON LLC
    Registration Number
    3014522540
    FEI Number
    3014522540
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    957 Panorama Trail S. Suite 190
    City
    Rochester
    State
    NY
    ZIP
    14625
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171410

    Owner / Operator

    Firm Name
    ICON LLC
    Operator Number
    10088441
    Address
    957 Panorama Trail S. Suite 190
    City
    Rochester
    State
    NY
    Postal Code
    14625
    Country
    US

    Products

    Device Name Product Code
    Recorder, Magnetic Tape, Medical DSH
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Electrocardiograph DPS
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrocardiograph Software For Over-The-Counter Use QDA

    Proprietary Names

    ePatch M12 ELI 150C H12+ Holter KardiaMobile

    Establishment Types

    Repack or Relabel Medical Device