The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Specular Microscope Cem-530.
| Device ID | K130565 |
| 510k Number | K130565 |
| Device Name: | SPECULAR MICROSCOPE CEM-530 |
| Classification | Microscope, Specular |
| Applicant | NIDEK CO., LTD. 300 BRICKSTONE SQUARE Andover, MA 01810 |
| Contact | Aron Shapiro |
| Correspondent | Aron Shapiro NIDEK CO., LTD. 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 | 2013-03-04 |
| Decision Date | 2013-11-27 |
| Summary: | summary |