Digital Amsler Grid

Neuro-Eye Diagnostic Systems LLC

The following data is part of a premarket notification filed by Neuro-eye Diagnostic Systems Llc with the FDA for Eyeqtester.

Pre-market Notification Details

Device IDK203594
510k NumberK203594
Device Name:EyeQTester
ClassificationDigital Amsler Grid
Applicant Neuro-Eye Diagnostic Systems LLC 2020 Quenby St. Houston,  TX  77005
ContactJade S. Schiffman
CorrespondentIsabella Schmitt
Proxima Clinical Research, Inc. 2450 Holcombe Blvd. Houston,  TX  77071
Product CodeQTW  
CFR Regulation Number886.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-09
Decision Date2022-09-07

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