The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Nidek Rs-3000.
| Device ID | K121622 |
| 510k Number | K121622 |
| Device Name: | NIDEK RS-3000 |
| 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 | 2012-06-01 |
| Decision Date | 2013-03-14 |
| Summary: | summary |