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

    XR-MX/1000

    K Number: K200965 · Decision Dec 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    25
    Review Days
    263

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    Basic Information

    Device Name
    XR-MX/1000
    K Number
    K200965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz Endoscopy America, Inc.
    Date Received
    April 10, 2020
    Decision Date
    December 29, 2020
    Product Code
    JAA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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