BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MILLER/NADLER GLARE TESTER

    K Number: K832762 · Decision Sep 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    3
    Review Days
    44

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    Basic Information

    Device Name
    MILLER/NADLER GLARE TESTER
    K Number
    K832762
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1630
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Titmus Optical, Inc.
    Date Received
    August 16, 1983
    Decision Date
    September 29, 1983
    Product Code
    HLX
    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
    HLX Photostimulator, Ac-Powered

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