BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEUROTRONICS, LLC

    Reg #: 1063925 · FEI: 3002459124 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    NEUROTRONICS, LLC
    Registration Number
    1063925
    FEI Number
    3002459124
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    13800 Tech City Circle, Suite 400
    City
    Alachua
    State
    FL
    ZIP
    32615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181709

    Owner / Operator

    Firm Name
    NEUROTRONICS, LLC
    Operator Number
    9030449
    Address
    13800 Tech City Circle, Suite 400, --
    City
    Alachua
    State
    FL
    Postal Code
    32615
    Country
    US
    Correspondent
    James C Smith

    Products

    Device Name Product Code
    Standard Polysomnograph With Electroencephalograph OLV
    Oximeter DQA
    Ventilatory Effort Recorder MNR
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Amplifier, Physiological Signal GWL
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Respiratory Effort Belt For Polysomnography SFK
    Full-Montage Standard Electroencephalograph GWQ
    Non-Normalizing Quantitative Electroencephalograph Software OLT

    Proprietary Names

    Serenity Piezo Sensor, Serenity Thermocouple Sensor Polysmith Sleep System Nomad Polysmith Sleep System, Model NTI7593 Polysmith Sleep System NTI6600 Serenity Body Position Sensor, Serenity RIP Sensors NomadAir NiteLynx PVDF Effort Sensor Live View Panel (LVP) Live View Panel (LVP) Pro

    Establishment Types

    Manufacture Medical Device