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

    CHARTERMED TPN-EVA BAGS

    K Number: K973103 · Decision Nov 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    4
    Review Days
    97

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    Basic Information

    Device Name
    CHARTERMED TPN-EVA BAGS
    K Number
    K973103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chartermed, Inc.
    Date Received
    August 19, 1997
    Decision Date
    November 24, 1997
    Product Code
    KPE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    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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    Other Clearances by Chartermed, Inc.

    K Number Device Name
    K902079 ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION
    K902464 CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY
    K901753 600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET