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

    Digital Automatic Wrist Blood Pressure Monitor MD3900

    K Number: K151583 · Decision Aug 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    21
    Review Days
    57

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    Basic Information

    Device Name
    Digital Automatic Wrist Blood Pressure Monitor MD3900
    K Number
    K151583
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Grandway Technology (Shenzhen) Limited
    Date Received
    June 11, 2015
    Decision Date
    August 7, 2015
    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 Grandway Technology (Shenzhen) Limited

    K Number Device Name
    K191593 Digital Automatic Blood Pressure Monitor MD36 Series
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    K163679 Digital Automatic Blood Pressure Monitor MD3600
    K163113 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
    K152483 Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
    K151587 Digital Automatic Wrist Blood Pressure Monitor MD3200
    K143735 Digital Automatic Blood Pressure Monitor MD2300
    K150373 Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]
    K143734 Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810
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