The following data is part of a premarket notification filed by Huizhou Xzing Technology Co., Ltd. with the FDA for Endofresh Digestive Endoscopy System.
| Device ID | K192704 |
| 510k Number | K192704 |
| Device Name: | Endofresh Digestive Endoscopy System |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | HuiZhou Xzing Technology Co., Ltd. 4th Floor, Building D, S-16-2 Southern Park HuiNan Hi-tech Industrial Park Huizhou, CN 516000 |
| Contact | Yonglin Ni |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, CN 200120 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-09-02 |