BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    iQFlex Pro

    Reg #: 3023344919 · FEI: 3023344919 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FSK CO., LTD
    Registration Number
    3023344919
    FEI Number
    3023344919
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    605, Gimpo MasterBizPark, 23, Taejang-ro 795beon-gil
    City
    Gimpo-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K221081

    Owner / Operator

    Firm Name
    FSK Co., Ltd
    Operator Number
    10085627
    Address
    605, Gimpo MasterBizPark, 23, Taejang-ro 795beon-gil
    City
    Gimpo-si
    State
    Gyeonggi
    Postal Code
    10090
    Country
    KR
    Correspondent
    JuSeon Youn

    US Agent

    Business Name
    First Source Inc.
    Contact Name
    Ron Viola
    Address
    3495 Winton Place Building E, Suite #1
    City
    Rochester
    State
    NY
    ZIP
    14623
    Country
    US
    Email
    [email protected]
    Phone
    800 3495980

    Products

    Device Name Product Code
    System, X-Ray, Mobile IZL

    Proprietary Names

    iQFlex Pro iQFlex M

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)