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— 510(k) K190831

Clearance details

Applicant

Nanjing Jusha Display Technology Co., Ltd.

Product code

Code GCJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2019-04-01

Decision date

2019-05-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Nanjing, CN

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• K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)2026-07-24

• K230728 — JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor2023-06-09
• K231170 — C350/C350G LCD Monitor; M550/M550G LCD Monitor2023-06-07
• K230723 — C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor2023-05-18
• K230643 — CP620G LCD monitor, CP620 LCD monitor2023-05-01
• K222121 — C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor2022-09-19

Death

39

Injury

1,638

Malfunction

28,216

Other

11

Total

29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →