BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BC-112B

    Reg #: 2080783 · FEI: 2080783 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    38
    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
    K011204

    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
    Standard Polysomnograph With Electroencephalograph OLV
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

    BC-112B TL-273T TL-052S QP-150AK EEG-9200A NEUROFAX, MODELS EEG-1100A with EEG-9100A AND JUNCTION BOX FUNCTIONS TL-201T LS-703AA QP-110AK JE-215AK JE-425A JL-550T1 KC-001A A/POUCHTRIFOLD TL-220T LS-703A KE-910A JE-921A JE-922A TL-271T JE-912AK JE-209A JE-212A TG-921T3 A/POUCH-JE922 NC-143E EEG-9100A LS-901AJ TL-274T JE-207A JE-217AK NE-134A JE-208A YZ-0226 JE-216AK QI-120A TL-062S NE-311A

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device