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

    Snap Insulin Pump System

    K Number: K142619 · Decision Dec 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    83
    Applicant Total
    2
    Review Days
    93

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    Basic Information

    Device Name
    Snap Insulin Pump System
    K Number
    K142619
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Asante Solutions, Inc.
    Date Received
    September 16, 2014
    Decision Date
    December 18, 2014
    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 Asante Solutions, Inc.

    K Number Device Name
    K122483 PEARL DIABETES MANAGEMENT SYSTEM