BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    myVision Track Model 005

    K Number: K143211 · Decision Mar 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    130

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    Basic Information

    Device Name
    myVision Track Model 005
    K Number
    K143211
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1330
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vital Art and Science Incorporated
    Date Received
    November 10, 2014
    Decision Date
    March 20, 2015
    Product Code
    HOQ
    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
    HOQ Grid, Amsler

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    Other Clearances by Vital Art and Science Incorporated

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