BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PE-210A

    Reg #: 3007962724 · FEI: 3007962724 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Nihon Kohden Tomioka Corporation
    Registration Number
    3007962724
    FEI Number
    3007962724
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    486 Nanokaichi
    City
    Gunma Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K110376

    Owner / Operator

    Firm Name
    NIHON KOHDEN CORP.
    Operator Number
    8030227
    Address
    1-31-4 NISHIOCHIAI, SHINJUKU-KU
    City
    TOKYO
    State
    JP-13
    Postal Code
    161-8560
    Country
    JP

    US Agent

    Business Name
    NIHON KOHDEN AMERICA, LLC.
    Contact Name
    Charlemagne Chua
    Address
    15353 Barranca Pkwy, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3303964

    Products

    Device Name Product Code
    Electrode, Cortical GYC
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

    PE-210A Nihon Kohden PE-210AK Switch Box for EEG-1200A

    Establishment Types

    Manufacture Medical Device