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

    DOLPHIN 3 FLUID MANAGEMENT SYSTEM

    K Number: K110852 · Decision Jul 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    55
    Applicant Total
    42
    Review Days
    113

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    Basic Information

    Device Name
    DOLPHIN 3 FLUID MANAGEMENT SYSTEM
    K Number
    K110852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gyrus Acmi, Inc.
    Date Received
    March 28, 2011
    Decision Date
    July 19, 2011
    Product Code
    HIG
    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
    HIG Insufflator, Hysteroscopic

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