The following data is part of a premarket notification filed by Neuro-eye Diagnostic Systems Llc with the FDA for Eyeqtester.
| Device ID | K203594 |
| 510k Number | K203594 |
| Device Name: | EyeQTester |
| Classification | Digital Amsler Grid |
| Applicant | Neuro-Eye Diagnostic Systems LLC 2020 Quenby St. Houston, TX 77005 |
| Contact | Jade S. Schiffman |
| Correspondent | Isabella Schmitt Proxima Clinical Research, Inc. 2450 Holcombe Blvd. Houston, TX 77071 |
| Product Code | QTW |
| CFR Regulation Number | 886.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-09 |
| Decision Date | 2022-09-07 |