BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MyLabX8

    Reg #: 1826555 · FEI: 1826555 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Esaote North America, Inc
    Registration Number
    1826555
    FEI Number
    1826555
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    11907 Exit Five Parkway
    City
    Fishers
    State
    IN
    ZIP
    46037
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192157

    Owner / Operator

    Firm Name
    ESAOTE S.P.A.
    Operator Number
    8021005
    Address
    via Enrico Melen 77
    City
    Genoa
    State
    Genova
    Postal Code
    16152
    Country
    IT

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    MyLabX8 MyLabX8 eXP 6450 Model

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198