BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    TL-274T

    Reg #: 8030229 · FEI: 3002807739 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    78
    Establishment Types
    1
    Classifications
    3

    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
    K080546

    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
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Standard Polysomnograph With Electroencephalograph OLV
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

    TL-274T NE-113A QI-124A A/RELAYBOX YL-104A A/NWB-HL7CS JL-550T1 EEG-1200A-T QI-122A KH-122A EEG-1200AA A/NIH8000 JE-207A YL-103A NC-143E QI-120A JE-120A-22 A/AIRPHOTICKIT BC-112B JE-922A NE-311A QP-110AK A/POUCHTRIFOLD LS-703A NK-CENTRAL-SW NK-REVSUITE-5 QD-120A A/ABC300-11MED NK-LS-901AJ NIHON KOHDEN EEG-1200A SERIES NEUROFAX A/TRACKTRANS A/DCIN1200 TL-271T JE-213A EEG-1260A JE-120A-24 JE-915A A/NWB-HL7NIS QP-160R-10 KC-001A JE-120A-23 JE-208A A/POUCH-JE922 A/QP-160A-VS-25 A/PHOTIC-3 A/SONYCART A/GCXCART KE-122A A/QP-160A-VS-10 TL-220T JE-227AK TL-062S AAA-17041 A/SONYCART-3 NK-CENTRAL-150 TG-921T3 QI-123A JE-214A EEG-1200A EEG-1200A-RAID NK-NEUROFAX-R NE-114A JE-212A NE-134A NK-REVSUITE-MU DI-120A EEG-1250A JE-225AK KH-121A NK-XPPSGRD-SFF JE-226AK NK-REVSUITE-10 QP-160AK JE-209A TL-052S JE-210A TL-201T JE-921A

    Establishment Types

    Manufacture Medical Device