BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ADVANCED BRAIN MONITORING, INC.

    Reg #: 3004964738 · FEI: 3004964738 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    ADVANCED BRAIN MONITORING, INC.
    Registration Number
    3004964738
    FEI Number
    3004964738
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2237 FARADAY AVE STE 100
    City
    CARLSBAD
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153412

    Owner / Operator

    Firm Name
    ADVANCED BRAIN MONITORING, INC.
    Operator Number
    9064303
    Address
    2237 FARADAY AVENUE, SUITE 100
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    DANIEL J LEVENDOWSKI

    Products

    Device Name Product Code
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Pillow, Cervical (For Mild Sleep Apnea) MYB
    Full-Montage Standard Electroencephalograph GWQ
    Reduced- Montage Standard Electroencephalograph OMC
    Ventilatory Effort Recorder MNR
    Device, Anti-Snoring LRK
    Standard Polysomnograph With Electroencephalograph OLV

    Proprietary Names

    Sleep Profiler Software Night Shift Therapy X10 System X24 System X4 Hardware Positional Sleep Assessment System (PoSAS) Software X4 Apnea Guard X8 System

    Establishment Types

    Manufacture Medical Device