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

    SYSTEMS OF SIGHT LOW VISION EYEWARE

    K Number: K854854 · Decision Feb 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    664
    Registration Numbers
    664
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    61

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    Basic Information

    Device Name
    SYSTEMS OF SIGHT LOW VISION EYEWARE
    K Number
    K854854
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5840
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Int'L Eye Care, Inc.
    Date Received
    December 5, 1985
    Decision Date
    February 4, 1986
    Product Code
    HOI
    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
    HOI Spectacle, Magnifying

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