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

    PREPARE HOME INFUSION PUMP

    K Number: K983634 · Decision Feb 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    87
    Applicant Total
    2
    Review Days
    132

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    Basic Information

    Device Name
    PREPARE HOME INFUSION PUMP
    K Number
    K983634
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Infusion Technologies, Inc.
    Date Received
    October 15, 1998
    Decision Date
    February 24, 1999
    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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    Other Clearances by Medical Infusion Technologies, Inc.

    K Number Device Name
    K970849 ENTERAL NUTRITION 1000 ML/500ML