BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇷🇺 Russian Federation

    SCENAR, MODEL 10

    K Number: K092117 · Decision May 28, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    2
    Review Days
    318

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    Basic Information

    Device Name
    SCENAR, MODEL 10
    K Number
    K092117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ritm Okb Zao
    Date Received
    July 14, 2009
    Decision Date
    May 28, 2010
    Product Code
    GZJ
    Advisory Committee
    Neurology
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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    Other Clearances by Ritm Okb Zao

    K Number Device Name
    K131513 SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY