BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    SMARTSTEP SYSTEM

    K Number: K023161 · Decision Dec 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    78

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    Basic Information

    Device Name
    SMARTSTEP SYSTEM
    K Number
    K023161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5575
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Andante Medical Device, Ltd.
    Date Received
    September 23, 2002
    Decision Date
    December 10, 2002
    Product Code
    IRN
    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
    IRN Device, Warning, Overload, External Limb, Powered

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