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

    H59 CRITICAL CARE MONITOR

    K Number: K791839 · Decision Oct 1, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    76
    Applicant Total
    8
    Review Days
    17

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    Basic Information

    Device Name
    H59 CRITICAL CARE MONITOR
    K Number
    K791839
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1110
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medtel Pty. , Ltd.
    Date Received
    September 14, 1979
    Decision Date
    October 1, 1979
    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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