BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software

    K Number: K173028 · Decision Jun 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    7
    Review Days
    266

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    Basic Information

    Device Name
    BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
    K Number
    K173028
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Healthstats International Pte. , Ltd.
    Date Received
    September 28, 2017
    Decision Date
    June 21, 2018
    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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