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

    FITE FIXATION TOY FOR OCULAR EXAM

    K Number: K801381 · Decision Jul 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    47

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    Basic Information

    Device Name
    FITE FIXATION TOY FOR OCULAR EXAM
    K Number
    K801381
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1290
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Fite Engineering Corp.
    Date Received
    June 11, 1980
    Decision Date
    July 28, 1980
    Product Code
    HPL
    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
    HPL Device, Fixation, Ac-Powered, Ophthalmic

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