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

    ARRHYTHMIA 9215

    K Number: K900366 · Decision Apr 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    46
    Review Days
    455

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    Basic Information

    Device Name
    ARRHYTHMIA 9215
    K Number
    K900366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    S & W Medico Teknik
    Date Received
    January 26, 1990
    Decision Date
    April 26, 1991
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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    K923418 9293/1 INTERFACE MODULE
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    K912815 NIBP 9225 COMBI
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