BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Medtronic O-Arm

    Reg #: 3036666444 · FEI: 3036666444 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FUJITA CO., LTD.
    Registration Number
    3036666444
    FEI Number
    3036666444
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5-1-1 Koujimachi
    City
    Chiyoda-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K092564

    Owner / Operator

    Firm Name
    FUJITA CO., LTD.
    Operator Number
    10092556
    Address
    5-1-1 Koujimachi
    City
    Chiyoda-ku
    State
    Tokyo
    Postal Code
    1020083
    Country
    JP
    Correspondent
    Tetsuya Hara

    Products

    Device Name Product Code
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO

    Proprietary Names

    Medtronic O-Arm

    Establishment Types

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