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510(k) Data Aggregation

    K Number
    K012553
    Device Name
    GSIBP BLOOD PRESSURE CUFF
    Manufacturer
    Date Cleared
    2001-08-17

    (9 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBALSHOP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Personnel properly trained in the use of blood pressurement devices use the GSIBP blood pressure cuff in conjunction with non-invasive blood pressure measurement systems. The device is non-sterile and is intended as a reusable multipatient device. It is available in child through large adult sizes.
    Device Description
    The device is comprised of one or two tubes attached to an inflatable latex bladder, which is covered with a stitched nylon or cotton cover. The device is wrapped around a patient's limb and secured by a hook and loop closure. The tubing connects to a non-invasive blood pressure measurement system. Sizes will include child through large adult. Each cuff will be packaged in a polyethylene bag.
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