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

    MENTOR HORIZON LOW VISION MAGNIFIER

    K Number: K915340 · Decision Mar 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    7
    Applicant Total
    18
    Review Days
    158

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    Basic Information

    Device Name
    MENTOR HORIZON LOW VISION MAGNIFIER
    K Number
    K915340
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5820
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mentor O & O, Inc.
    Date Received
    October 24, 1991
    Decision Date
    March 30, 1992
    Product Code
    HJG
    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
    HJG System, Reading, Television, Closed-Circuit

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