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

    NIOX ARTICLE NO: 02-1000

    K Number: DEN030001 · Decision Apr 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    43

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    Basic Information

    Device Name
    NIOX ARTICLE NO: 02-1000
    K Number
    DEN030001
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    862.3080
    Medical Specialty
    Clinical Toxicology
    Decision
    Unknown
    Applicant
    Aerocrine AB
    Date Received
    March 18, 2003
    Decision Date
    April 30, 2003
    Product Code
    MXA
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MXA System, Test, Breath Nitric Oxide

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    Other Clearances by Aerocrine AB

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