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

    OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System

    K Number: K152361 · Decision Jan 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    147

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    Basic Information

    Device Name
    OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
    K Number
    K152361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Liebel-Flarsheim Company, LLC
    Date Received
    August 20, 2015
    Decision Date
    January 14, 2016
    Product Code
    IZQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IZQ Injector, Contrast Medium, Automatic

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    Other Clearances by Liebel-Flarsheim Company, LLC

    K Number Device Name
    K193010 Liebel-Flarsheim IBP Transfer Set