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

    MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045

    K Number: K050197 · Decision Oct 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    617

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    Basic Information

    Device Name
    MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
    K Number
    K050197
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Minitube of America, Inc.
    Date Received
    January 27, 2005
    Decision Date
    October 6, 2006
    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 Minitube of America, Inc.

    K Number Device Name
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