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

    ELDONCARD

    K Number: K790282 · Decision May 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    ELDONCARD
    K Number
    K790282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9175
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Nordisk Infuser System
    Date Received
    February 13, 1979
    Decision Date
    May 4, 1979
    Product Code
    KSZ
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KSZ System, Test, Automated Blood Grouping And Antibody

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    Other Clearances by Nordisk Infuser System

    K Number Device Name
    K860492 NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE