The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd with the FDA for Jusha-c61 Lcd Monitor.
| Device ID | K141679 |
| 510k Number | K141679 |
| Device Name: | JUSHA-C61 LCD MONITOR |
| Classification | Display, Diagnostic Radiology |
| Applicant | NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 8A, BLOCK 1, NANJING INTL SERVICE OUTSOURCING MANSION NO. 301, HANZHONGMEN STREET Nanjing, Jiangsu, CN 210036 |
| Contact | Li Le |
| Correspondent | Li Le NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 8A, BLOCK 1, NANJING INTL SERVICE OUTSOURCING MANSION NO. 301, HANZHONGMEN STREET Nanjing, Jiangsu, 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 | 2014-06-23 |
| Decision Date | 2014-08-01 |
| Summary: | summary |