BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEURONETRIX SOLUTIONS, LLC

    Reg #: 3011184129 · FEI: 3011184129 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    NEURONETRIX SOLUTIONS, LLC
    Registration Number
    3011184129
    FEI Number
    3011184129
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1044 E Chestnut St Ste 8
    City
    Louisville
    State
    KY
    ZIP
    40204
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141316

    Owner / Operator

    Firm Name
    Neuronetrix Solutions, LLC
    Operator Number
    10048856
    Address
    1044 E Chestnut Street, Suite 8
    City
    Louisville
    State
    KY
    Postal Code
    40204
    Country
    US
    Correspondent
    Kalford Fadem

    Products

    Device Name Product Code
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Stimulator, Auditory, Evoked Response GWJ
    Reduced- Montage Standard Electroencephalograph OMC

    Proprietary Names

    GWJ / STIMULATOR, AUDITORY, EVOKED RESPONSE

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility