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510(k) Data Aggregation

    K Number
    K131905
    Device Name
    SOLID GEL PAD
    Manufacturer
    Date Cleared
    2013-07-18

    (22 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLUEMTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or liquid or fluid.
    Device Description
    The SOLID GEL PAD is ultrasound gel of the solid-state, generally used for ultrasound scanning for imaging diagnosis or ultrasound stimulator for treatment. The gel pad will be sold for single patient/procedure, disposable use. The SOLID GEL PAD is 9cm x 9cm aqueous, flexible. disposable ultrasound standoff for use in difficult to visualize and near field areas, or when gels alone won't do. Disposability eliminates the risk of cross contamination in diagnostic and therapeutic ultrasound procedures. It requires only gentle, even pressure. The SOLID GEL PAD is especially very useful for using ultrasound over areas that are bony such as fingers, hands, wrists, elbows, and ankles. It also allows visualization of superficial structures.
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