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

    EPX-4440HD DIGITAL VIDEO PROCESSOR

    K Number: K140149 · Decision Aug 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    39
    Review Days
    212

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    Basic Information

    Device Name
    EPX-4440HD DIGITAL VIDEO PROCESSOR
    K Number
    K140149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Medical Systems U.S.A, Inc.
    Date Received
    January 22, 2014
    Decision Date
    August 22, 2014
    Product Code
    PEA
    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
    PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement

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