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

    KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER

    K Number: K974389 · Decision Feb 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    8
    Applicant Total
    9
    Review Days
    90

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    Basic Information

    Device Name
    KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
    K Number
    K974389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Innovations, Inc.
    Date Received
    November 21, 1997
    Decision Date
    February 19, 1998
    Product Code
    HFN
    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
    HFN Transducer, Pressure, Intrauterine

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    Other Clearances by Clinical Innovations, Inc.

    K Number Device Name
    K030691 FETAL SPIRAL ELECTRODE, MODEL FSE07000
    K022023 COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
    K003458 SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
    K981260 KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
    K974563 COLPO CUP CVC-2000
    K973746 PRE-FILLED SYRINGE FOR KOALA IUP
    K954955 STORC INTRAUTERINE PRESSURE CATHETER
    K940681 CLEARVIEW UTERINE MANIPULATOR