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

    TYPE 9225 NIBP

    K Number: K890005 · Decision May 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    46
    Review Days
    128

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    Basic Information

    Device Name
    TYPE 9225 NIBP
    K Number
    K890005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    S & W Medico Teknik
    Date Received
    January 3, 1989
    Decision Date
    May 11, 1989
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    K923418 9293/1 INTERFACE MODULE
    K911611 SYSTEM ATHENA, MODIFICATION
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    K912000 TYPE INTERFACE 9271/1 INCUBATOR/WARMER
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