BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NEAT 001

    K Number: K250058 · Decision Apr 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    NEAT 001
    K Number
    K250058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brain Electrophysiology Laboratory Company, LLC
    Date Received
    January 10, 2025
    Decision Date
    April 10, 2025
    Product Code
    OLZ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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    Other Clearances by Brain Electrophysiology Laboratory Company, LLC

    K Number Device Name
    K241513 Sourcerer