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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ERGOSELECT/GE

    K Number: K112121 · Decision Oct 31, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    464

    Basic Information

    Device Name
    ERGOSELECT/GE
    K Number
    K112121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ERGOLINE GMBH
    Date Received
    July 25, 2011
    Decision Date
    October 31, 2012
    Product Code
    ISD
    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
    ISD Exerciser, Measuring

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