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

    CO2mbiLED

    K Number: K201096 · Decision Jun 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    23
    Applicant Total
    25
    Review Days
    60

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    Basic Information

    Device Name
    CO2mbiLED
    K Number
    K201096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz Endoscopy America, Inc.
    Date Received
    April 24, 2020
    Decision Date
    June 23, 2020
    Product Code
    FCX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FCX Insufflator, Automatic Carbon-Dioxide For Endoscope

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