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

    UC-2000 UTERINE CATHERIZATION SYSTEM

    K Number: K791633 · Decision Sep 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    UC-2000 UTERINE CATHERIZATION SYSTEM
    K Number
    K791633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Life Support, Inc.
    Date Received
    August 21, 1979
    Decision Date
    September 17, 1979
    Product Code
    HFO
    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
    HFO Recorder, Pressure, Intrauterine

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