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

    SERIES 400 GASTROENTEROLOGY SYSTEM

    K Number: K944620 · Decision Apr 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    3
    Review Days
    219

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    Basic Information

    Device Name
    SERIES 400 GASTROENTEROLOGY SYSTEM
    K Number
    K944620
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Marks & Murase
    Date Received
    September 20, 1994
    Decision Date
    April 27, 1995
    Product Code
    FET
    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
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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    Other Clearances by Marks & Murase

    K Number Device Name
    K950417 EPX-310 VIDEO PROCESSOR (ENDOSCOPY)
    K934422 NASOPHARYNGOSCOPE