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

    SATURN 5 LASER

    K Number: K141434 · Decision Feb 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    7
    Review Days
    264

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    Basic Information

    Device Name
    SATURN 5 LASER
    K Number
    K141434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6200
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Research Instruments , Ltd.
    Date Received
    May 30, 2014
    Decision Date
    February 18, 2015
    Product Code
    MRX
    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
    MRX System, Assisted Reproduction Laser

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