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

    MANDOMETER III

    K Number: DEN070014 · Decision Mar 31, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    1380

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    Basic Information

    Device Name
    MANDOMETER III
    K Number
    DEN070014
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    882.5060
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Ab Mando
    Date Received
    June 20, 2007
    Decision Date
    March 31, 2011
    Product Code
    OBV
    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
    OBV Eating Disorder Conditioning Tool