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

    ZOLL M SERIES NIBP OPTION

    K Number: K032363 · Decision Oct 31, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    33
    Review Days
    92

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    Basic Information

    Device Name
    ZOLL M SERIES NIBP OPTION
    K Number
    K032363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zoll Medical Corp
    Date Received
    July 31, 2003
    Decision Date
    October 31, 2003
    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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    Other Clearances by Zoll Medical Corp

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    K042007 ZOLL E SERIES DEFIBRILLATOR
    K042302 ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
    K042417 ZOLL M SERIES ETC02 LOFLO OPTION
    K033474 ZOLL AED PLUS
    K032691 ZOLL AUTOCLAVABLE INTERNAL HANDLES
    K032439 ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
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