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

    KADANCE 2000

    K Number: K012492 · Decision Nov 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    91

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    Basic Information

    Device Name
    KADANCE 2000
    K Number
    K012492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1240
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kada Research, Inc.
    Date Received
    August 3, 2001
    Decision Date
    November 2, 2001
    Product Code
    LBB
    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
    LBB Dynamometer, Ac-Powered

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