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

    ALL-IN-ONE CONTAINER

    K Number: K090096 · Decision Jan 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    61
    Review Days
    15

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    Basic Information

    Device Name
    ALL-IN-ONE CONTAINER
    K Number
    K090096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Healthcare Corporation
    Date Received
    January 15, 2009
    Decision Date
    January 30, 2009
    Product Code
    KPE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPE Container, I.V.

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