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510(k) Data Aggregation

    K Number
    K993316
    Device Name
    UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE
    Manufacturer
    UEDA AVANCER CORP.
    Date Cleared
    2000-06-09

    (249 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    UEDA AVANCER CORP.

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

    The Ueda Udex Super BP-2000 Automatic Blood Pressure Recording Device is designed to provide signals from which systolic and diastolic pressures can be derived based on the ausculatory blood pressure measuring method proposed by Korotkoff. The device also measures pulse rate. This device is for use by adult population ( 18 years and older.) This is a non-invasive electronic sphygmomanometer.

    Device Description

    Automatic Blood Pressure Recording Device

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a blood pressure device. It does not contain acceptance criteria, detailed study information, or performance metrics in the format requested. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not specify the studies performed to demonstrate this equivalence, nor does it provide performance data.

    Therefore, I cannot extract the information required to populate the table and answer the specific questions about acceptance criteria and study details. The document primarily focuses on regulatory clearance based on substantial equivalence, rather than a detailed presentation of performance study results.

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