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510(k) Data Aggregation

    K Number
    K033978

    Validate with FDA (Live)

    Device Name
    ADAM
    Manufacturer
    ASTRO-MED, INC.
    Date Cleared
    2004-02-18

    (57 days)

    Product Code
    GWQ
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K992291,K974587,K021807
    Predicate For
    K050425
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ADAM amplifier system is intended for recording routine EEG and EEG associated with long term monitoring for epilepsy. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.

    Device Description

    The ADAM amplifier system is an EEG Amplifier System.

    AI/ML Overview

    The provided text is a 510(k) summary for the Grass-Telefactor ADAM EEG Amplifier System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot populate the table or answer the questions you've posed based on the given input text. The 510(k) summary is primarily concerned with establishing substantial equivalence, not with detailing performance studies with specific statistical metrics and ground truth methods.

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