BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NeuroStar System Software

    Reg #: 3004824012 · FEI: 3004824012 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Neuronetics Inc.
    Registration Number
    3004824012
    FEI Number
    3004824012
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3222 Phoenixville Pike
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230029

    Owner / Operator

    Firm Name
    Neuronetics Inc
    Operator Number
    10027686
    Address
    3222 Phoenixville Pike
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    Amanda E Pentecost

    Products

    Device Name Product Code
    Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder QCI
    Transcranial Magnetic Stimulator OBP

    Proprietary Names

    NeuroStar System Software TrakStar Patient Data Management System NeuroStar Advanced Therapy System

    Establishment Types

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