BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    AIDERA DIASEND

    K Number: K083221 · Decision Feb 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    47
    Applicant Total
    2
    Review Days
    95

    Basic Information

    Device Name
    AIDERA DIASEND
    K Number
    K083221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aidera AB
    Date Received
    October 31, 2008
    Decision Date
    February 3, 2009
    Product Code
    MRZ
    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
    MRZ Accessories, Pump, Infusion

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    Other Clearances by Aidera AB

    K Number Device Name
    K101806 AIDERA DIASEND SYSTEM