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

    ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)

    K Number: K873914 · Decision Dec 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    6
    Applicant Total
    15
    Review Days
    77

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    Basic Information

    Device Name
    ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)
    K Number
    K873914
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1290
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Richmond Products, Inc.
    Date Received
    September 25, 1987
    Decision Date
    December 11, 1987
    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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