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

    ANIMAS MODEL IR1250 INSULIN INFUSION PUMP

    K Number: K042873 · Decision Dec 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    83
    Applicant Total
    10
    Review Days
    53

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    Basic Information

    Device Name
    ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
    K Number
    K042873
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Animas Corp.
    Date Received
    October 18, 2004
    Decision Date
    December 10, 2004
    Product Code
    LZG
    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
    LZG Pump, Infusion, Insulin

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