The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd. with the FDA for R190/r191 Lcd Monitor.
| Device ID | K183494 |
| 510k Number | K183494 |
| Device Name: | R190/R191 LCD Monitor |
| Classification | Display, Diagnostic Radiology |
| 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 | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-04-05 |