The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Rs-3000 Advance.
| Device ID | K132323 |
| 510k Number | K132323 |
| Device Name: | RS-3000 ADVANCE |
| Classification | Tomography, Optical Coherence |
| Applicant | NIDEK CO., LTD. 1667 RIDGEWOOD RD Wadsworth, OH 44281 |
| Contact | Lena Sattler |
| Correspondent | Lena Sattler NIDEK CO., LTD. 1667 RIDGEWOOD RD Wadsworth, OH 44281 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-25 |
| Decision Date | 2014-02-19 |
| Summary: | summary |