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

    MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER

    K Number: K030531 · Decision Jun 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    83
    Applicant Total
    9
    Review Days
    118

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    Basic Information

    Device Name
    MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
    K Number
    K030531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Minimed, Inc.
    Date Received
    February 19, 2003
    Decision Date
    June 17, 2003
    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 Minimed, Inc.

    K Number Device Name
    K031541 PARADIGMPAL, MODEL MMT-7330
    K031390 MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
    K021974 MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
    K010377 MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
    K001827 PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325
    K001829 MINIMED PARADIGM INSULIN PUMP, MODEL 511
    K001832 PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318
    K001828 PARADIGM 1.5ML RESERVOIR, MODEL 326