BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor

    K Number: K190831 · Decision May 31, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    26
    Review Days
    60

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    Basic Information

    Device Name
    E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
    K Number
    K190831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanjing Jusha Display Technology Co., Ltd.
    Date Received
    April 1, 2019
    Decision Date
    May 31, 2019
    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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    Other Clearances by Nanjing Jusha Display Technology Co., Ltd.

    K Number Device Name
    K230728 JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
    K231170 C350/C350G LCD Monitor; M550/M550G LCD Monitor
    K230723 C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
    K230643 CP620G LCD monitor, CP620 LCD monitor
    K222121 C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
    K212231 C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
    K200742 JUSHA-CP610 LCD Monitor
    K190848 JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
    K183496 JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
    K183494 R190/R191 LCD Monitor
    Search all 26 clearances from Nanjing Jusha Display Technology Co., Ltd. →