510(k) K190831— 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

Substantially Equivalent

Nanjing Jusha Display Technology Co., Ltd.

Clearance details

Applicant: Nanjing Jusha Display Technology Co., Ltd.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-01
Decision date: 2019-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Adverse events under product code GCJ

product code GCJ

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.