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

    KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

    K Number: K030359 · Decision Nov 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    9
    Review Days
    276

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    Basic Information

    Device Name
    KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    K Number
    K030359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kodon(Tianjin)Electronic&Electrical Apparatus Co.,
    Date Received
    February 3, 2003
    Decision Date
    November 6, 2003
    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 Kodon(Tianjin)Electronic&Electrical Apparatus Co.,

    K Number Device Name
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    K070395 KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    K052450 KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
    K052676 KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    K051847 KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
    K042418 KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    K030358 KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR