BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prager Shell

    Reg #: 3004181533 · FEI: 3004181533 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ESI, INC.
    Registration Number
    3004181533
    FEI Number
    3004181533
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2915 EVEREST LN N
    City
    Minneapolis
    State
    MN
    ZIP
    55447
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080119

    Owner / Operator

    Firm Name
    ESI, INC.
    Operator Number
    9056190
    Address
    2915 EVEREST LN. N., --
    City
    Plymouth
    State
    MN
    Postal Code
    55447
    Country
    US
    Correspondent
    THOMAS A BURBA

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Prager Shell

    Establishment Types

    Manufacture Medical Device