BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP

    K Number: K181393 · Decision Feb 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    2
    Review Days
    262

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    Basic Information

    Device Name
    Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP
    K Number
    K181393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Valmed S.R.L.
    Date Received
    May 29, 2018
    Decision Date
    February 15, 2019
    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 Valmed S.R.L.

    K Number Device Name
    K101412 EVA TPN BAG