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

    Blood Pressure Monitor

    K Number: K220676 · Decision Aug 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    17
    Review Days
    174

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    Basic Information

    Device Name
    Blood Pressure Monitor
    K Number
    K220676
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Received
    March 8, 2022
    Decision Date
    August 29, 2022
    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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