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

    4K UHD LCD Monitor OEV321UH

    K Number: K220069 · Decision Mar 9, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    1391
    Applicant Total
    60
    Review Days
    58

    Basic Information

    Device Name
    4K UHD LCD Monitor OEV321UH
    K Number
    K220069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Medical Systems Corp.
    Date Received
    January 10, 2022
    Decision Date
    March 9, 2022
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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