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

    EVA EMPTY SOLUTION CONTAINER

    K Number: K030888 · Decision Apr 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    5
    Review Days
    12

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    Basic Information

    Device Name
    EVA EMPTY SOLUTION CONTAINER
    K Number
    K030888
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Metrix Co.
    Date Received
    March 21, 2003
    Decision Date
    April 2, 2003
    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 Metrix Co.

    K Number Device Name
    K895922 METRICARE EMPTY CONTAINER SYSTEMS
    K895924 METRICARE DRUG RESERVOIRS
    K895923 METRICARE ENTERAL FEEDING SYSTEM
    K761201 ECHO-CARDIOTRACE, AUTOMATIC