The following data is part of a premarket notification filed by Optical Diagnostics, Inc. with the FDA for Aniseikonia Inspector.
| Device ID | K013110 |
| 510k Number | K013110 |
| Device Name: | ANISEIKONIA INSPECTOR |
| Classification | Haploscope |
| Applicant | OPTICAL DIAGNOSTICS, INC. 490 MT. FURY CIRCLE SW Issaquah, WA 98027 |
| Contact | Joyce De Wit |
| Correspondent | Joyce De Wit OPTICAL DIAGNOSTICS, INC. 490 MT. FURY CIRCLE SW Issaquah, WA 98027 |
| Product Code | HJT |
| CFR Regulation Number | 886.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-11 |
| Decision Date | 2001-12-19 |
| Summary: | summary |