BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T

    K Number: K041789 · Decision Jul 15, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    4
    Review Days
    13

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    Basic Information

    Device Name
    NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T
    K Number
    K041789
    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
    July 2, 2004
    Decision Date
    July 15, 2004
    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
    K002655 DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550
    K992328 FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
    K990380 (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700