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510(k) Data Aggregation

    K Number
    K180232
    Device Name
    DAEHAN Disposable CUP Electrodes
    Manufacturer
    Daehan Medical Systems Co., Ltd.
    Date Cleared
    2019-04-03

    (429 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Daehan Medical Systems Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CUP Electrodes are intended for non-invasive use with recording and monitoring equipment,(active and reference), of Electroencephalograph (EEG), electromyography (EMG)and Evoked Potentials(EP).
    Device Description
    A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological signals. In other words cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph(EEG), Electromyograph(EMG), and Evoked Potentials(EP) and the electroencephalograph/evoked potentials reading is completely non-invasive procedure that can be applied to children and adult patients. The electrodes are delivered non-sterile and are available in disposable version. DAEHAN Disposable CUP electrodes are for single patient use only. The electrodes have a disc manufactured of molded ABS, Ag/agcl plated. The disc is permanently adhered to a lead wire. The insulated lead wires terminate using a molded touch proof connector (DIN 42 802) for electrical safety.
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    K Number
    K180247
    Device Name
    DAEHAN Adhesive Surface Electrodes
    Manufacturer
    Daehan Medical Systems Co., Ltd.
    Date Cleared
    2018-11-01

    (276 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Daehan Medical Systems Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DAEHAN Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the, patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.
    Device Description
    DAEHAN Adhesive Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of stimulating, monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single-patient/multiple application use and are very flexible. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations.
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    K Number
    K161566
    Device Name
    DMS Disposable Subdermal Needle Electrodes
    Manufacturer
    Daehan Medical Systems Co., Ltd.
    Date Cleared
    2016-12-21

    (198 days)

    Product Code
    GXZ, DAT
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    Daehan Medical Systems Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DMS Disposable Subdermal Needle Electrodes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
    Device Description
    The DMS Disposable Subdermal Needle Electrodes are supplied sterile and intended for single use. This subdermal needle electrodes can be used to record the neurological and neurophysiological evoked potentials. The connector is provided with touch-proof and cannot be connected to an AC outlet. This connector is designed for connecting the recording or monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals. The DMS Disposable Subdermal Needle Electrodes are supplied sterile.
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