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    K Number
    K992283
    Device Name
    ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
    Manufacturer
    AIRSEP CORP.
    Date Cleared
    1999-08-27

    (51 days)

    Product Code
    OLV,GWQ
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Artisan™ is intended to be used by Physicians or trained technicians for acquisition of EEG and polygrasomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations commonly used in clinics. It does not involve any patient monitoring or diagnosis.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a device named "Artisan™ Acquisition System for EEG and Polysomnography." It confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance requirements.

    However, it does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about sample sizes for test or training sets, data provenance, expert qualifications, or adjudication methods for ground truth.
    • Information about MRMC studies, standalone algorithm performance, or the type of ground truth used.

    Therefore, I cannot fulfill your request based on the provided text.

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