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

    KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M

    K Number: K981260 · Decision Sep 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    28
    Applicant Total
    9
    Review Days
    169

    Basic Information

    Device Name
    KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
    K Number
    K981260
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4340
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CLINICAL INNOVATIONS, INC.
    Date Received
    April 6, 1998
    Decision Date
    September 22, 1998
    Product Code
    HDB
    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
    HDB Extractor, Vacuum, Fetal

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