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510(k) Data Aggregation

    K Number
    K103783
    Device Name
    EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
    Manufacturer
    FIAB S.P.A.
    Date Cleared
    2011-06-16

    (171 days)

    Product Code
    LDD
    Regulation Number
    870.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIAB S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EURO DEFI PADS series of disposable multi-function electrodes are indicated for the following clinical applications: - external defibrillation - synchronized cardioversion - cardiac stimulation - ECG monitoring EURO DEFI PADS series of disposable multi-function electrodes provide the conductive interface between the defibrillator and the patient's skin. These devices are available with different connectors compatible for use with different defibrillators. All devices are non-sterile and for single-use only. The pediatric model of EURO DEFI PADS disposable multi-function electrodes is intended for use on pediatric patient under eight years of age, or weighting less than 25 kg, the device is designed to deliver a maximum of 100 joule. The adult model of EURO DEFI PADS disposable multi-function electrodes is intended for use on adult patients and children older than eight years or greater than 25 kg, the device is designed to deliver a maximum of 360 joule. The radio-transparent adult model EURO DEFI PADS disposable multi-function electrodes for adult patient use only, is well suited for certain clinical applications involving radiographic viewing.
    Device Description
    FIAB EURO DEFI PADS series of disposable multi-function electrodes are made by a couple of pre-gelled self-adhesive pad-type electrodes consisting of foam backing, laminated metallic substrate, conductive hydrogel, cabling and molded connector. The electrodes are passive devices providing the conductive interface between the defibrillator and the patient's skin. Each couple of electrodes is permanently attached with lead wires that join together in a safety connector suitable for direct connection to devices - both monophasic and biphasic of the main defibrillators brands nowadays present on the market. The products are packaged in pairs inside water-vapor proof, heat sealed, non-transparent, aluminum/PE pouches. FIAB EURO DEFI PADS series of disposable multi-function electrodes are available in the following versions: adult, adult radiotransparent, pediatric.
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