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

    DIB INFUSOR

    K Number: K955849 · Decision Aug 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    87
    Applicant Total
    6
    Review Days
    222

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    Basic Information

    Device Name
    DIB INFUSOR
    K Number
    K955849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novacon Corp.
    Date Received
    December 27, 1995
    Decision Date
    August 5, 1996
    Product Code
    MEB
    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
    MEB Pump, Infusion, Elastomeric

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