The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd with the FDA for Jusha-c31 Medical Display.
| Device ID | K131389 |
| 510k Number | K131389 |
| Device Name: | JUSHA-C31 MEDICAL DISPLAY |
| Classification | System, Image Processing, Radiological |
| Applicant | NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 7TH FLOOR, 982. CONGYUN RD. BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 7TH FLOOR, 982. CONGYUN RD. BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-14 |
| Decision Date | 2013-09-06 |
| Summary: | summary |