FDA.reportPublic FDA data

510(k) K203594

Device
EyeQTester
Applicant
Neuro-Eye Diagnostic Systems LLC
510(k) number
K203594
Product code
QTW  
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-07
Date received
2020-12-09
Regulation
886.1330
Classification name
Digital Amsler Grid
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jade S. Schiffman
Address
2020 Quenby St. Houston TX US 77005 77005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases