BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA

    K Number: K884122 · Decision Apr 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    46
    Review Days
    207

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    Basic Information

    Device Name
    TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA
    K Number
    K884122
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    S & W Medico Teknik
    Date Received
    September 30, 1988
    Decision Date
    April 25, 1989
    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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    Other Clearances by S & W Medico Teknik

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    K930134 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT
    K923418 9293/1 INTERFACE MODULE
    K911611 SYSTEM ATHENA, MODIFICATION
    K922314 VENTILATOR INTERFACE 9291/4
    K912815 NIBP 9225 COMBI
    K912000 TYPE INTERFACE 9271/1 INCUBATOR/WARMER
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