BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Neuralynx, Inc.

    Reg #: 3009391672 · FEI: 3009391672 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Neuralynx, Inc.
    Registration Number
    3009391672
    FEI Number
    3009391672
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    105 Commercial Dr
    City
    Bozeman
    State
    MT
    ZIP
    59715
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110967

    Owner / Operator

    Firm Name
    Neuralynx, Inc.
    Operator Number
    10038712
    Address
    105 Commercial Drive
    City
    Bozeman
    State
    MT
    Postal Code
    59715
    Country
    US
    Correspondent
    Kelly Moeykens

    Products

    Device Name Product Code
    Reduced- Montage Standard Electroencephalograph OMC
    Electrode, Cortical GYC

    Proprietary Names

    ATLAS Neurophysiology System Atlas Stim Headbox (HD) Atlas Headbox Interface Cable (NK) Atlas Headbox Expansion Panel ATLAS Stim Headbox Software Atlas Headbox Interface Cable (Touchproof) Atlas Stim Headbox (Touchproof) ATLAS Stim Headbox (NK) ASHB FIBER OPTIC DUPLEX CONN 2m Atlas Headbox Interface Cable (HD) ASHB FIBER OPTIC DUPLEX CONN 7m

    Establishment Types

    Manufacture Medical Device