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

    TIMEX HEALTHCHECK DIGITAL BP MONITOR

    K Number: K841616 · Decision Jun 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    35

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    Basic Information

    Device Name
    TIMEX HEALTHCHECK DIGITAL BP MONITOR
    K Number
    K841616
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Timex Medical Products Corp.
    Date Received
    May 1, 1984
    Decision Date
    June 5, 1984
    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 Timex Medical Products Corp.

    K Number Device Name
    K841595 HEALTHCHECK HOME PREGNANCY TEST KIT
    K840228 HEALTHCHECK AUTO INFLATE DIGITAL BP
    K821437 DIGITAL BLOOD PRESSURE METER
    K821436 ELECTRONIC DIGITAL THERMOMETER