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510(k) Data Aggregation

    K Number
    K051539
    Date Cleared
    2005-08-05

    (56 days)

    Product Code
    Regulation Number
    870.1120
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    TRICOT BLOOD PRESSURE CUFF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TRICOT blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in child through large adult sizes.

    Device Description

    The TRICOT blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in child through large adult sizes.

    AI/ML Overview

    The provided document does not contain any information about acceptance criteria, device performance, or related studies. It is a K051539 510(k) clearance document for a blood pressure cuff and primarily focuses on administrative details, intended use, and the FDA's substantial equivalence determination.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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