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

    EEVA 2.0

    K Number: DEN120015 · Decision Jun 6, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    4
    Review Days
    651

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    Basic Information

    Device Name
    EEVA 2.0
    K Number
    DEN120015
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    884.6195
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Applicant
    Auxogyn, Inc.
    Date Received
    August 24, 2012
    Decision Date
    June 6, 2014
    Product Code
    PBH
    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
    PBH Embryo Image Assessment System, Assisted Reproduction

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    Other Clearances by Auxogyn, Inc.

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