BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AcuViz Pocket

    Reg #: 3017955833 · FEI: 3017955833 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    FCU CO., LTD.
    Registration Number
    3017955833
    FEI Number
    3017955833
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F, 62-4, Techno 1-ro, Yuseong-gu
    City
    Daejeon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K210468

    Owner / Operator

    Firm Name
    FCU Co., Ltd.
    Operator Number
    10082644
    Address
    2F, 62-4, Techno 1-ro, Yuseong-gu
    City
    Daejeon
    State
    KR-30
    Postal Code
    34014
    Country
    KR
    Correspondent
    Seline Kim

    US Agent

    Business Name
    ACERTERA
    Contact Name
    Levi Moore
    Address
    1950 Lefthand Creek Lane
    City
    Longmont
    State
    CO
    ZIP
    80501
    Country
    US
    Email
    [email protected]
    Phone
    303 8348413

    Products

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

    Proprietary Names

    AcuViz Pocket SC1

    Establishment Types

    Manufacture Medical Device