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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM

    K Number: K120634 · Decision Jul 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    123
    Review Days
    124

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    Basic Information

    Device Name
    U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
    K Number
    K120634
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taidoc Technology Corporation
    Date Received
    March 1, 2012
    Decision Date
    July 3, 2012
    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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