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510(k) Data Aggregation

    K Number
    K100620
    Device Name
    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
    Manufacturer
    HARVARD MEDICAL DEVICES LTD.
    Date Cleared
    2010-07-02

    (120 days)

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

    Blood Pressure Monitor, KUBE/Kinetik Branded BPM1K Series is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

    Device Description

    Non-Invasive Blood Pressure Measurement System

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Harvard-Medical-Devices Limited regarding their KUBE/Kinetik Branded BPM1K Series blood pressure monitor. While it confirms the device's substantial equivalence to a predicate device and outlines regulatory obligations, it does not contain the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested table and detailed study information based on the text provided. This document is an FDA approval letter, not a study report or a detailed summary of the testing performed.

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