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

    EYEPORT VISION TRAINING SYSTEM

    K Number: K051684 · Decision Mar 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    267

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    Basic Information

    Device Name
    EYEPORT VISION TRAINING SYSTEM
    K Number
    K051684
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1290
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exercise Your Eyes, Inc.
    Date Received
    June 23, 2005
    Decision Date
    March 17, 2006
    Product Code
    NXR
    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
    NXR Fixation, Vision Training, Binocular