The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Advanced Vision Information System (navis).
| Device ID | K013694 |
| 510k Number | K013694 |
| Device Name: | NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) |
| Classification | System, Image Management, Ophthalmic |
| Applicant | NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-07 |
| Decision Date | 2002-11-19 |
| Summary: | summary |