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

    t:slim Insulin Delivery System

    K Number: K160056 · Decision Jul 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    83
    Applicant Total
    25
    Review Days
    195

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    Basic Information

    Device Name
    t:slim Insulin Delivery System
    K Number
    K160056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tandem Diabetes Care, Inc.
    Date Received
    January 12, 2016
    Decision Date
    July 25, 2016
    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 Tandem Diabetes Care, Inc.

    K Number Device Name
    K260429 Control-IQ+ technology
    K253074 Tandem Mobi insulin pump with interoperable technology
    K250792 t:slim X2 insulin pump with interoperable technology
    K250798 Control-IQ+ technology
    K243823 Control-IQ+ technology
    K241078 Tandem Mobi Insulin Pump with interoperable technology
    K240309 Tandem Mobi insulin pump with interoperable technology
    K232380 t:slim X2 Insulin Pump with Interoperable Technology
    K232382 Control-IQ Technology
    K233044 Tandem Mobi insulin pump with interoperable technology
    Search all 25 clearances from Tandem Diabetes Care, Inc. →