BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    RI Witness Embryology Heated Plate

    K Number: K160504 · Decision Jul 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    145

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    Basic Information

    Device Name
    RI Witness Embryology Heated Plate
    K Number
    K160504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Research Instruments Limited
    Date Received
    February 24, 2016
    Decision Date
    July 18, 2016
    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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