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

    ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING

    K Number: K895763 · Decision Dec 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    5
    Review Days
    87

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    Basic Information

    Device Name
    ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING
    K Number
    K895763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Healthdyne Cardiovascular, Inc.
    Date Received
    September 26, 1989
    Decision Date
    December 22, 1989
    Product Code
    KXO
    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
    KXO Monitor, Pressure, Intrauterine

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    Other Clearances by Healthdyne Cardiovascular, Inc.

    K Number Device Name
    K901643 ISOFLO(TM) AMNIOCENTESIS TRAY
    K901382 ISOFLO(TM) HIGH PRESSURE INJECTION LINES
    K901084 ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.
    K900665 DRESSING CHANGE KIT