BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Geri Embryo Incubator and Geri Dish

    K Number: K180304 · Decision Apr 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    6
    Review Days
    77

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    Basic Information

    Device Name
    Geri Embryo Incubator and Geri Dish
    K Number
    K180304
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.6120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genea Biomedx Pty, Ltd.
    Date Received
    February 2, 2018
    Decision Date
    April 20, 2018
    Product Code
    MQG
    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
    MQG Accessory, Assisted Reproduction

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    Other Clearances by Genea Biomedx Pty, Ltd.

    K Number Device Name
    K180188 Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
    K171736 Geri Embryo Incubator and Geri Dish
    K170498 Gems Oocyte Retrieval Buffer ORB-20, ORB-50
    K162409 Gems Vitrification Set, Gems Warming Set
    K161261 Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase