BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    GE Optima 660 CT

    Reg #: 3025398421 · FEI: 3025398421 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Y2000 MEDICAL ELECTRONICS CC
    Registration Number
    3025398421
    FEI Number
    3025398421
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1017 Martha Street, Eldoraigne, Ext 1
    City
    Centurion Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K131576

    Owner / Operator

    Firm Name
    Y2000 Medical Electronics cc
    Operator Number
    10091215
    Address
    1017 Martha Street, Eldoraigne, Ext 1
    City
    Centurion
    State
    Gauteng
    Postal Code
    0157
    Country
    ZA
    Correspondent
    Abraham A Wessels

    US Agent

    Business Name
    Block Imaging Parts & Service
    Contact Name
    Grace Lyon
    Address
    1845 Cedar St
    City
    Holt
    State
    MI
    ZIP
    48842
    Country
    US
    Email
    [email protected]
    Phone
    517 6688800

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    GE Optima 660 CT

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device