BEUDAMED
    FDA Registration Active 🇷🇺 Russian Federation

    Neuron-Spectrum-4/P with Neuron-Spectrum.NET software

    Reg #: 3006418479 · FEI: 3006418479 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    NEUROSOFT LTD
    Registration Number
    3006418479
    FEI Number
    3006418479
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 Voronin Street
    City
    Ivanovo Ivanovskaya Oblast'
    Country
    RU

    Regulatory Submissions

    510(k) Number
    K133995

    Owner / Operator

    Firm Name
    Neurosoft LTD
    Operator Number
    10035792
    Address
    5 Voronin Street
    City
    Ivanovo
    State
    Ivanovskaya Oblast'
    Postal Code
    153032
    Country
    RU
    Correspondent
    Mikhail U Durdin

    US Agent

    Business Name
    TeleEMG, LLC
    Contact Name
    Joe F Jabre
    Address
    7304 Beverly Blvd #357
    City
    Los Angeles
    State
    CA
    ZIP
    90036
    Country
    US
    Email
    [email protected]
    Phone
    617 8403253

    Products

    Device Name Product Code
    Standard Polysomnograph With Electroencephalograph OLV
    Full-Montage Standard Electroencephalograph GWQ
    Non-Normalizing Quantitative Electroencephalograph Software OLT

    Proprietary Names

    Neuron-Spectrum-4/P with Neuron-Spectrum.NET software Neuron-Spectrum-3 with Neuron-Spectrum.NET software Neuron-Spectrum-4 with Neuron-Spectrum.NET software Neuron-Spectrum-1 with Neuron-Spectrum.NET software Neuron-Spectrum-2 with Neuron-Spectrum.NET software NoetherTech

    Establishment Types

    Manufacture Medical Device