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

    FOCUS TOUCH CONCEPTION SYSTEM

    K Number: K112200 · Decision Sep 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    402

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    Basic Information

    Device Name
    FOCUS TOUCH CONCEPTION SYSTEM
    K Number
    K112200
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intimate Bridge 2 Conception, Inc.
    Date Received
    August 1, 2011
    Decision Date
    September 6, 2012
    Product Code
    OBB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OBB Kit, Conception-Assist, Home Use

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