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

    Arm Blood Pressure Monitor

    K Number: K180435 · Decision Jan 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    317

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    Basic Information

    Device Name
    Arm Blood Pressure Monitor
    K Number
    K180435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alicn Medical (Shenzhen), Inc.
    Date Received
    February 20, 2018
    Decision Date
    January 3, 2019
    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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