BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TL-274T

    Reg #: 2080783 · FEI: 2080783 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    78
    Establishment Types
    2
    Classifications
    3

    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
    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

    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

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device