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

    LIGHTSCOPE SET

    K Number: K894557 · Decision Aug 7, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    11
    Applicant Total
    6
    Review Days
    18

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    Basic Information

    Device Name
    LIGHTSCOPE SET
    K Number
    K894557
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1250
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Optik
    Date Received
    July 20, 1989
    Decision Date
    August 7, 1989
    Product Code
    HRW
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRW Dynamometer, Nonpowered

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    K894558 MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET