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510(k) Data Aggregation

    K Number
    K092558
    Device Name
    WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES
    Manufacturer
    HARVARD MEDICAL DEVICES LTD.
    Date Cleared
    2010-03-17

    (209 days)

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

    WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES

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

    Wrist Type Blood Pressure Monitor is for use at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The theoretical range of cuff circumference is limited to 14-19.5cm.

    Device Description

    Wrist Type Blood Pressure Monitor, HMBPM-005/Kinetik Branded BPM2 Series

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a Wrist Type Blood Pressure Monitor. It does not contain the acceptance criteria, reported device performance, or details of any studies demonstrating the device meets such criteria.

    Therefore, I cannot provide the requested information from the given input. The letter primarily confirms the device's substantial equivalence to a predicate device and outlines general regulatory compliance requirements. It does not delve into the specific technical performance or study results.

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