BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇭🇰 Hong Kong

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

    K Number: K092558 · Decision Mar 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    209

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    Basic Information

    Device Name
    WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES
    K Number
    K092558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Harvard Medical Devices , Ltd.
    Date Received
    August 20, 2009
    Decision Date
    March 17, 2010
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by Harvard Medical Devices , Ltd.

    K Number Device Name
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    K081061 HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES