BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    QP-160AK

    Reg #: 8030229 · FEI: 3002807739 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    NIHON KOHDEN TOMIOKA PRODUCTION CENTER
    Registration Number
    8030229
    FEI Number
    3002807739
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-1 Tajino
    City
    TOMIOKA-SHI Gunma
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K163644

    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
    Amplitude-Integrated Electroencephalograph OMA
    Burst Suppression Detection Software For Electroencephalograph ORT
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB

    Proprietary Names

    QP-160AK

    Establishment Types

    Manufacture Medical Device