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

    GENUCOM

    K Number: K834462 · Decision Feb 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    52

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    Basic Information

    Device Name
    GENUCOM
    K Number
    K834462
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.1615
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Far Orthopedics, Inc.
    Date Received
    December 19, 1983
    Decision Date
    February 9, 1984
    Product Code
    LYH
    Advisory Committee
    Physical Medicine
    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
    LYH Arthrometer

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    Other Clearances by Far Orthopedics, Inc.

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