BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Positional Sleep Assessment System (PoSAS) Software

    Reg #: 3004964738 · FEI: 3004964738 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ADVANCED BRAIN MONITORING, INC.
    Registration Number
    3004964738
    FEI Number
    3004964738
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2237 FARADAY AVE STE 100
    City
    CARLSBAD
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172799

    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
    Ventilatory Effort Recorder MNR

    Proprietary Names

    Positional Sleep Assessment System (PoSAS) Software

    Establishment Types

    Manufacture Medical Device