BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET

    K Number: K001461 · Decision Sep 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    4
    Review Days
    124

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    Basic Information

    Device Name
    TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
    K Number
    K001461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biometrix , Ltd.
    Date Received
    May 10, 2000
    Decision Date
    September 11, 2000
    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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