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

    DANA DIABECARE IIS

    K Number: K063126 · Decision Feb 2, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    83
    Applicant Total
    4
    Review Days
    112

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    Basic Information

    Device Name
    DANA DIABECARE IIS
    K Number
    K063126
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sooil Development Co., Ltd.
    Date Received
    October 13, 2006
    Decision Date
    February 2, 2007
    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 Sooil Development Co., Ltd.

    K Number Device Name
    K071418 DANA 3CC SYRINGE INSULIN RESERVOIR
    K022317 DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
    K001604 DANA DIABECARE