BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550

    K Number: K002655 · Decision Sep 6, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    4
    Review Days
    12

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    Basic Information

    Device Name
    DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550
    K Number
    K002655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meditec Co., Ltd.
    Date Received
    August 25, 2000
    Decision Date
    September 6, 2000
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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 Meditec Co., Ltd.

    K Number Device Name
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    K990380 (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700