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

    Arm Blood Pressure Monitor

    K Number: K193456 · Decision Jul 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    4
    Review Days
    216

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    Basic Information

    Device Name
    Arm Blood Pressure Monitor
    K Number
    K193456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ningbo Ranor Medical Science & Technology Co., Ltd.
    Date Received
    December 13, 2019
    Decision Date
    July 16, 2020
    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 Ningbo Ranor Medical Science & Technology Co., Ltd.

    K Number Device Name
    K251143 Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
    K200578 Infrared Thermometer Model Number RN-50A,RN-50B
    K200471 Infrared Thermometer Model Number RN-60A,RN-60B