The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd with the FDA for Jusha-m53 Medical Display.
| Device ID | K150842 |
| 510k Number | K150842 |
| Device Name: | JUSHA-M53 Medical Display |
| Classification | Display, Diagnostic Radiology |
| Applicant | NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 301, HANZHONGMEN STREET, 8F BLOCK A, NO.1 Nanjing, CN 210036 |
| Contact | Jing Ma |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Services., Ltd. 7th Floor, Jingui Business Building, No. 982 Congyun Rd., Baiyun District Guangzhou, CN 510420 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-30 |
| Decision Date | 2015-04-28 |
| Summary: | summary |