LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974495
    Device Name
    NEUROAMP EEG AMPLIFIER
    Manufacturer
    NEUROCORP, LTD.
    Date Cleared
    1998-02-26

    (90 days)

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

    The NeuroAmp EEG/EP amplifier is an accessory device of integrated systems used for the recording of brain bio-electrical activity. It intended use is for the amplification of brain bioelectrical signals which are recorded from scalp applied electrodes, and analyzed for brain function evaluation.

    Device Description

    The NeuroAmp EEG/EP amplifier is an accessory device of integrated systems used for the recording of brain bio-electrical activity.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance results of the NeuroAmp EEG Amplifier. The document is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to a predicate device and can be marketed. It outlines regulatory information but does not include a scientific study's details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1