BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    YZ3 PORTABLE SLIT LAMP

    K Number: K131711 · Decision May 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    2
    Review Days
    332

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    Basic Information

    Device Name
    YZ3 PORTABLE SLIT LAMP
    K Number
    K131711
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Suzhou 66 Vision Tech Co., Ltd.
    Date Received
    June 11, 2013
    Decision Date
    May 9, 2014
    Product Code
    HJO
    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
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

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    Other Clearances by Suzhou 66 Vision Tech Co., Ltd.

    K Number Device Name
    K052599 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A