BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TG-921T3

    Reg #: 2080783 · FEI: 2080783 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    NIHON KOHDEN AMERICA, INC.
    Registration Number
    2080783
    FEI Number
    2080783
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    15353 Barranca Pkwy
    City
    Irvine
    State
    CA
    ZIP
    92618
    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

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device