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

    KRONAMAX KUBE

    K Number: K893903 · Decision Nov 29, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    183

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    Basic Information

    Device Name
    KRONAMAX KUBE
    K Number
    K893903
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1500
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Physicians Digital Co.
    Date Received
    May 30, 1989
    Decision Date
    November 29, 1989
    Product Code
    KQX
    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
    KQX Goniometer, Ac-Powered

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    Other Clearances by Physicians Digital Co.

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