BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Endoscope Reprocessor OER-Elite

    K Number: K201920 · Decision Sep 1, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    57
    Applicant Total
    60
    Review Days
    53

    Basic Information

    Device Name
    Endoscope Reprocessor OER-Elite
    K Number
    K201920
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Medical Systems Corp.
    Date Received
    July 10, 2020
    Decision Date
    September 1, 2020
    Product Code
    FEB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FEB Accessories, Cleaning, For Endoscope

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