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

    RHEA CUP

    K Number: K112165 · Decision May 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    15
    Applicant Total
    8
    Review Days
    301

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    Basic Information

    Device Name
    RHEA CUP
    K Number
    K112165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5400
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apex Medical Technologies, Inc.
    Date Received
    July 28, 2011
    Decision Date
    May 24, 2012
    Product Code
    HHE
    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
    HHE Cup, Menstrual

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