BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    OneTouch Via On-Demand Insulin Delivery System

    K Number: K163357 · Decision Jun 7, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    189

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    OneTouch Via On-Demand Insulin Delivery System
    K Number
    K163357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifescan Europe, A Division of Cilag GmbH
    Date Received
    November 30, 2016
    Decision Date
    June 7, 2017
    Product Code
    OPP
    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
    OPP Pump, Infusion, Insulin Bolus

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OPP), ordered by most recent decision date.

    CeQur Simplicity™ On-Demand Insulin Delivery System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CeQur Simplicity™ On-Demand Insulin Delivery System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CeQur Simplicity™ On-Demand Insulin Delivery System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FINESSE PERSONAL INSULIN DELIVERY PATCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all