The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Anterior Eye-segment Analysis System.
| Device ID | K991284 |
| 510k Number | K991284 |
| Device Name: | ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
| Contact | Jerry Tsutsumi |
| Correspondent | Jerry Tsutsumi NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-15 |
| Decision Date | 1999-08-06 |
| Summary: | summary |