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

    MODEL 78231D CARDIAC OUTPUT MODULE

    K Number: K850568 · Decision Apr 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    230
    Review Days
    56

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    Basic Information

    Device Name
    MODEL 78231D CARDIAC OUTPUT MODULE
    K Number
    K850568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Hewlett-Packard Co.
    Date Received
    February 12, 1985
    Decision Date
    April 9, 1985
    Product Code
    DXG
    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
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function

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