K-number	K203594
Device name	EyeCTester
Applicant	Neuro-Eye Diagnostic Systems, LLC
Product code	QTW
Device class	Class I
Decision date	Sep 7, 2022
Decision	Substantially Equivalent
Regulation	886.1330

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Source

View the full FDA submission: accessdata.fda.gov

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EyeCTester

Everything you need for a 510(k) submission. Nothing you don't.