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

    INFUSION IV SET

    K Number: K001879 · Decision Nov 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    518

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    Basic Information

    Device Name
    INFUSION IV SET
    K Number
    K001879
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nirvi Intl. USA
    Date Received
    June 20, 2000
    Decision Date
    November 20, 2001
    Product Code
    LRS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRS I.V. Start Kit

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