Data / Medical devices / United States / Neuro-Eye Diagnostic Systems, LLC
Neuro-Eye Diagnostic Systems, LLC: FDA-registered device maker in Houston, TX, United States, 1 510(k) clearance
Neuro-Eye Diagnostic Systems, LLC is registered with the FDA (registration 3042954736) in Houston, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042954736
- Address
- 2020 Quenby St, Houston, TX, United States, 77005
- Owner or operator
- Neuro-Eye Diagnostic Systems, LLC (10094829)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 31, 2025
- Registered through
- 2026
- Brand names listed
- EyeCTester Monitoring App
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digital Amsler Grid | QTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 7, 2022 | K203594 | EyeCTester | QTW | Substantially Equivalent | Neuro-Eye Diagnostic Systems, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 7, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.