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510(k) Data Aggregation

    K Number
    K012011
    Device Name
    MODIFICATION TO A620 EEG
    Manufacturer
    STOELTING CO.
    Date Cleared
    2001-10-10

    (104 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EEG/Neurofeedback is indicated where general relaxation training is desired.

    The Model A620-3 EEG biofeedback instrument is used by professionals for general relaxation training of patients.

    Device Description

    Autogenics Model A620-3 EEG Biofeedback Instrument

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the Autogenics Model A620-3 EEG Biofeedback Instrument. This document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and administrative information. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in clinical study summaries or technical performance reports.

    Therefore, I cannot provide the requested table and answers based on the given input.

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