BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    IV-eye

    K Number: K152088 · Decision Feb 24, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    212

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    Basic Information

    Device Name
    IV-eye
    K Number
    K152088
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novarix Limited
    Date Received
    July 27, 2015
    Decision Date
    February 24, 2016
    Product Code
    KZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZA Device, Vein Location, Liquid Crystal

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