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510(k) Data Aggregation

    K Number
    K062893
    Device Name
    KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A
    Manufacturer
    SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LTD.
    Date Cleared
    2007-02-05

    (131 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Abbreviated
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The blood pressure meter Models: XJ-2001AC, XJ-2002AS and XJ-2003A are non-invasive blood pressure measurement systems which are intended to measure the diastolic and systolic blood pressure, pulse rate of the adult individual through using inflatable cuff at home. The cuff circumference is limited to 8.6614 inches to 12.60 inches.

    Device Description

    Blood Pressure Meter Model: XJ-2001AC, XJ-2002AS and XJ-2003A

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter and an Indications for Use statement for a blood pressure meter. It does not contain the acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications based on the provided text. This document confirms the device's clearance based on substantial equivalence to a predicate device, not on specific performance data presented in a study.

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