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

    GLUCOPRO EVO INFUSION PUMP

    K Number: K013309 · Decision Jun 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    83
    Applicant Total
    5
    Review Days
    263

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    Basic Information

    Device Name
    GLUCOPRO EVO INFUSION PUMP
    K Number
    K013309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nipro Diabetes Systems, Inc.
    Date Received
    October 4, 2001
    Decision Date
    June 24, 2002
    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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    Other Clearances by Nipro Diabetes Systems, Inc.

    K Number Device Name
    K071613 AMIGO INSULIN PUMP
    K050312 AMIGO INSULIN PUMP
    K014114 GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX
    K011120 GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES