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510(k) Data Aggregation

    K Number
    K081151
    Device Name
    COMPUMEDICS NEUVO
    Manufacturer
    COMPUMEDICS USA, LTD.
    Date Cleared
    2008-09-08

    (138 days)

    Product Code
    GWQ, GWE, GWF, GWJ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUMEDICS USA, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compumedics Neuvo System is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short- latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.
    Device Description
    The Compumedics Neuvo System is intended for measuring of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/traincd EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician. The Neuvo Amplifier System is an EEG/ERP/EP amplifier and data acquisition system. The amplifier and data acquisition clectronics are housed in a small enclosure (Headbox) placed near the patient, and into which individual clectrodes, collections of electrodes, may be connected. Additionally a high density electrode cap connector is provided on the Headbox. The Headbox also contains a connector for the interconnect cable to the System Unit. The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer. The system operates under the software control of a host computer over an Ethernet 100BaseT interface. Data flows from the Neuvo amplifier over this interface.
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    K Number
    K040194
    Device Name
    COMPUMEDICS SUMMIT IP
    Manufacturer
    COMPUMEDICS USA, LTD.
    Date Cleared
    2004-04-23

    (86 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUMEDICS USA, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Summit IP is intended for use in private practices or hospital environments for the detection of human respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. Signals from patient worn thoracic and abdominal sensors are demodulated, amplified and summed to provide electrical signals suitable for connection to the inputs of physiological recording equipment. The Summit IP unit is only to be used under the direction and supervision of a physician. The Summit IP unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units. The Summit IP unit is not intended for use on infant or pediatric patients.
    Device Description
    The Compumedics Summit IP consists of a small plastic enclosure with two input sockets for connection to Compumedics respiratory effort bands (Thoracic and Abdominal), and output sockets for the Thoracic, Abdominal and Sum channels. The Sum channel is a weighted surn of the Thoracic and Abdominal signals. The output channels may be connected to the inputs of standard physiological equipment for the purpose of recording or monitoring respiratory effort. The Summit IP is powered by a user-replaceable 1.5 volt battery and automatically switches on when any or both sensors are connected.
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    K Number
    K033052
    Device Name
    CONDUCTIVE EEG ELECTROLYTE
    Manufacturer
    COMPUMEDICS USA, LTD.
    Date Cleared
    2003-12-17

    (79 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUMEDICS USA, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quik gel is intended to enhance electrical conductivity by facilitating transmission of the electrode-to-skin interface. It also helps the electrodes adhere to the patient.
    Device Description
    A jellylike mass consisting of salts combined with carbohydrate thickening agent, hypo-allergenic organic emollient, anti-fungal agents all in a aqueous solvent.
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