The following data is part of a premarket notification filed by Chongqing Yeasn Science-technology Co., Ltd with the FDA for Slit Lamp, Model: Yf-100.
| Device ID | K161764 |
| 510k Number | K161764 |
| Device Name: | SLIT LAMP, Model: YF-100 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | CHONGQING YEASN SCIENCE-TECHNOLOGY CO., LTD 5 DANLONG ROAD Nan'an District, CN 400060 |
| Contact | Bing Hu |
| Correspondent | Iris Fung SGS-CTSC STANDARDS TECHNICAL SERVICES CO., LTD. 198 KEZHU ROAD, SCIENTECH PARK GUANGZHOU ECONOMIC & TECHNOLOGY DEVELOPMENT DISTRICT Guangzhou, CN |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-27 |
| Decision Date | 2017-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971922135030 | K161764 | 000 |