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

    KRONAMAX HUMAN PERFORMANCE LAB

    K Number: K902219 · Decision Jul 25, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    KRONAMAX HUMAN PERFORMANCE LAB
    K Number
    K902219
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1925
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Physicians Digital Co.
    Date Received
    May 16, 1990
    Decision Date
    July 25, 1990
    Product Code
    IKK
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IKK System, Isokinetic Testing And Evaluation

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