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

    DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143

    K Number: K092683 · Decision Sep 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    24

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    Basic Information

    Device Name
    DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
    K Number
    K092683
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shanghai Little Doctor Co. Limited
    Date Received
    September 1, 2009
    Decision Date
    September 25, 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 Shanghai Little Doctor Co. Limited

    K Number Device Name
    K093359 1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133