BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Ambu Duodeno System

    K Number: K201098 · Decision Jul 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    Ambu Duodeno System
    K Number
    K201098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ambu Innovation GmbH
    Date Received
    April 24, 2020
    Decision Date
    July 17, 2020
    Product Code
    FDT
    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
    FDT Duodenoscope And Accessories, Flexible/Rigid

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