BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    NIOX VERO

    K Number: K170983 · Decision Nov 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    233

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    Basic Information

    Device Name
    NIOX VERO
    K Number
    K170983
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3080
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Circassia AB
    Date Received
    April 3, 2017
    Decision Date
    November 22, 2017
    Product Code
    MXA
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    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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