Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042954736

FEI Number

3042954736

Entity Name

Neuro-Eye Diagnostic Systems, LLC

City/State/Country

Houston, TX, US

Establishment Address

2020 Quenby St, Houston, TX 77005, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Neuro-Eye Diagnostic Systems, LLC (Owner Number: 10094829)

Owner / Operator Contact Address

2020 Quenby Street, Houston, TX 77005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203594

PMA Number

N/A

All Registered Proprietary Names

EyeCTester Monitoring App

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QTW	Digital Amsler Grid	Ophthalmic	Class 1	886.1330	2025-12-31

Official Correspondent

Jade Schiffman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neuro-Eye Diagnostic Systems, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042954736. Last updated year: 2026. Please use registration number 3042954736 when referencing this establishment in official correspondence.