The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Slit Lamp Sl-2000.
| Device ID | K163564 |
| 510k Number | K163564 |
| Device Name: | SLIT LAMP SL-2000 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | NIDEK CO., LTD. 34-14 Maehama, Hiroishicho Gamagori, JP 443-0038 |
| Contact | Yoneji Mizuno |
| Correspondent | Toshio Murata NIDEK INC. 47651 Westinghouse Drive Fremont, CA 94539 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-05-19 |
| Summary: | summary |