EyeCTester
K-Number: K203594 · 2022-09-07
ApplicantNeuro-Eye Diagnostic Systems, LLC
Decision Date2022-09-07
Product CodeQTW
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
EyeCTester is a medical device manufactured by Neuro-Eye Diagnostic Systems, LLC. It received FDA 510(k) clearance on 2022-09-07 under approval number K203594. The device is classified under product code QTW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EyeCTester?
EyeCTester is a medical device that received FDA 510(k) clearance on 2022-09-07. It is manufactured by Neuro-Eye Diagnostic Systems, LLC. The 510(k) number is K203594.
When was EyeCTester approved by the FDA?
EyeCTester received FDA 510(k) clearance on 2022-09-07, under approval number K203594.
What company makes EyeCTester?
EyeCTester is manufactured by Neuro-Eye Diagnostic Systems, LLC.
What is the FDA product code for EyeCTester?
The FDA product code for EyeCTester is QTW.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.