BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Olympic Brain Monitor

    Reg #: 3010611950 · FEI: 3010611950 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Natus Neurology Incorporated
    Registration Number
    3010611950
    FEI Number
    3010611950
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3150 Pleasant View Road
    City
    Middleton
    State
    WI
    ZIP
    53562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123079

    Owner / Operator

    Firm Name
    Natus Medical Incorporated
    Operator Number
    9004873
    Address
    3150 Pleasant View Road
    City
    Middleton
    State
    WI
    Postal Code
    53562
    Country
    US
    Correspondent
    Sanjay Mehta

    Products

    Device Name Product Code
    Amplitude-Integrated Electroencephalograph OMA
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB
    Reduced- Montage Standard Electroencephalograph OMC

    Proprietary Names

    Olympic Brain Monitor OBM-Recognize

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)