The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Opd-scan, Models Ark-10000 And Ark-9000.
| Device ID | K003299 |
| 510k Number | K003299 |
| Device Name: | OPD-SCAN, MODELS ARK-10000 AND ARK-9000 |
| Classification | Keratoscope, Ac-powered |
| Applicant | NIDEK CO., LTD. 21911 ERIE LN. Lake Forest, CA 92630 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson NIDEK CO., LTD. 21911 ERIE LN. Lake Forest, CA 92630 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-20 |
| Decision Date | 2001-03-09 |