BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    VX130 Ophthalmic Diagnostic Device

    K Number: K162067 · Decision Apr 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    57
    Applicant Total
    2
    Review Days
    272

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    Basic Information

    Device Name
    VX130 Ophthalmic Diagnostic Device
    K Number
    K162067
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luneau Sas
    Date Received
    July 26, 2016
    Decision Date
    April 24, 2017
    Product Code
    HKX
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HKX Tonometer, Ac-Powered

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