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

    ORTHOTONE

    K Number: K872111 · Decision Nov 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    534

    Basic Information

    Device Name
    ORTHOTONE
    K Number
    K872111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1510
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    ORTHOTONE CORP.
    Date Received
    June 1, 1987
    Decision Date
    November 16, 1988
    Product Code
    HLL
    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
    HLL Monitor, Eye Movement

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