The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd with the FDA for 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.
| Device ID | K190831 |
| 510k Number | K190831 |
| 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 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Nanjing Jusha Display Technology Co., Ltd Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, CN 210036 |
| Contact | Zilong Liang |
| Correspondent | Zilong Liang Nanjing Jusha Display Technology Co., Ltd Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, CN 210036 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-05-31 |