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510(k) Data Aggregation

    K Number
    K140874
    Device Name
    GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF
    Date Cleared
    2014-09-02

    (151 days)

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

    SHANGHAI GOAHUI RUBBER AND PLASTIC COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GH disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. The GH reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
    Device Description
    Both devices comprise tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb, secured by hook and loop closure, and used to measure the patient's blood pressure. The device tubing is connected to a non-invasive blood pressure measurement system.
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