BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TG-921T3

    Reg #: 3030154814 · FEI: 3030154814 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Nihon Kohden America Fulfillment Center
    Registration Number
    3030154814
    FEI Number
    3030154814
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    20091 Ellipse, Suite 100
    City
    Foothill Ranch
    State
    CA
    ZIP
    92610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050833

    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

    Products

    Device Name Product Code
    Full-Montage Standard Electroencephalograph GWQ
    Standard Polysomnograph With Electroencephalograph OLV

    Proprietary Names

    TG-921T3 TL-052S JE-921A TL-062S TL-201T TL-220T

    Establishment Types

    Manufacture Medical Device