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510(k) Data Aggregation

    K Number
    K993654
    Device Name
    NEUROCOMP
    Manufacturer
    NEUROCYBERNETICS
    Date Cleared
    2000-01-27

    (90 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROCYBERNETICS

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

    NeuroComp is indicated for use in data acquisition and operant conditioning of the EEG. The device is to be used under the supervision of health professionals. This system is used for general relaxation.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a device called "NeuroComp." It primarily deals with regulatory approval and does not contain detailed information about acceptance criteria or specific studies demonstrating device performance. Therefore, I cannot provide the requested information.

    The letter states that the device is "substantially equivalent" to previously marketed devices, meaning it meets regulatory requirements but not necessarily specific performance criteria outlined in a study in this particular document.

    To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification for the NeuroComp device.

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