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510(k) Data Aggregation

    K Number
    K211747
    Device Name
    Reusable NIBP Cuff
    Date Cleared
    2021-09-23

    (108 days)

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

    Shenzhen Coreray Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reusable NIBP 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 adult size.
    Device Description
    Reusable NIBP Cuff is a reusable accessory used in conjunction with a non-invasive blood pressure measurement system. It comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. Reusable NIBP Cuff is made of PU synthetic leather (Cuff), TPU film (bladder) and TPU (Air Hose), and the PU synthetic leather is the material used to contacting with the patient's intact skin.
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