BEUDAMED
    Product Code: ORT FDA class 2 21 CFR 882.1400

    Burst Suppression Detection Software For Electroencephalograph

    Neurology

    The Burst Suppression Detection Software for Electroencephalograph (product code ORT) is a neurology software device that automatically marks or identifies EEG waveforms exhibiting rhythmic patterns of burst suppression, assisting clinicians in identifying such events during the review and annotation of prolonged EEG traces. It can also quantify characteristics of burst suppression such as inter-burst interval or count, with all output subject to verification by a qualified user. As an FDA Class 2 device under regulation 882.1400, it requires 510(k) premarket clearance and falls within the Neurology specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    ORT
    Device Class
    FDA class 2
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K092625 WAVESTATE NEUROMONITOR

    FEI Numbers

    This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.