The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Specular Microscope Cem-530.
| Device ID | K173980 |
| 510k Number | K173980 |
| Device Name: | Specular Microscope CEM-530 |
| Classification | Microscope, Specular |
| Applicant | Nidek Co., Ltd. 34-14 Maehama, Hiroishi-cho Gamagori, JP 443-0038 |
| Contact | Yoneji Mizuno |
| Correspondent | Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 |
| Product Code | NQE |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2018-03-14 |
| Summary: | summary |