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510(k) Data Aggregation

    K Number
    K081159
    Device Name
    HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES
    Manufacturer
    HARVARD MEDICAL DEVICES LTD.
    Date Cleared
    2008-08-08

    (116 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

    Kinetik BPM1 Series is for use at home and is a non-invasive blood pressurement system intended to measure the diastolic and systelle 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.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for a non-invasive blood pressure measurement system (Kinetik BPM1 Series). The document states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided input. The document is primarily a regulatory clearance, not a performance study report.

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