BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PSG-1100 Sleep Diagnostic System

    Reg #: 3021736577 · FEI: 3021736577 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Nihon Vinyl Cord Corporation - Kodama Second Factory
    Registration Number
    3021736577
    FEI Number
    3021736577
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1404-1 Kodama, Kodama-machi
    City
    Honjo-shi Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K120888

    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 Parkway
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3303964

    Products

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

    Proprietary Names

    PSG-1100 Sleep Diagnostic System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)