BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES

    K Number: K092514 · Decision Dec 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    7
    Review Days
    109

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    Basic Information

    Device Name
    UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
    K Number
    K092514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hangzhou Hua'An Medical & Health Instruments Co.,
    Date Received
    August 17, 2009
    Decision Date
    December 4, 2009
    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 Hangzhou Hua'An Medical & Health Instruments Co.,

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    K041694 DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER
    K041692 INFRARED EAR THERMOMETER, ET-100 SERIES
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