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

    MODIFIED CARDIOCAP MONITOR

    K Number: K862455 · Decision Sep 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    76
    Applicant Total
    55
    Review Days
    89

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    Basic Information

    Device Name
    MODIFIED CARDIOCAP MONITOR
    K Number
    K862455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1110
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Datex Division Instrumentarium Corp.
    Date Received
    June 27, 1986
    Decision Date
    September 24, 1986
    Product Code
    DSK
    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
    DSK Computer, Blood-Pressure

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