BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Generation 2 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

    Reg #: 3011845821 · FEI: 3011845821 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    NEUROSIGMA, INC.
    Registration Number
    3011845821
    FEI Number
    3011845821
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    10960 Wilshire Blvd., Suite 1910
    City
    Los Angeles
    State
    CA
    ZIP
    90024
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233293

    Owner / Operator

    Firm Name
    NeuroSigma, Inc.
    Operator Number
    10060896
    Address
    10960 Wilshire Blvd., Suite 1910
    City
    Los Angeles
    State
    CA
    Postal Code
    90024
    Country
    US
    Correspondent
    Patrick Miller

    Products

    Device Name Product Code
    Transcutaneous Nerve Stimulator For Adhd QGL

    Proprietary Names

    Generation 2 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198