The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Specular Microscope Cem- 530.
| Device ID | K151706 |
| 510k Number | K151706 |
| Device Name: | Specular Microscope CEM- 530 |
| Classification | Microscope, Specular |
| Applicant | NIDEK CO., LTD. 34-14 MACHAMA, 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 | 2015-06-24 |
| Decision Date | 2016-03-17 |
| Summary: | summary |