EyeCTester— 510(k) K203594

Substantially Equivalent

Neuro-Eye Diagnostic Systems, LLC

FDA 510(k) clearance K203594 for EyeCTester, Substantially Equivalent on 2022-09-07. Applicant: Neuro-Eye Diagnostic Systems, LLC.

Clearance details

Applicant: Neuro-Eye Diagnostic Systems, LLC
Product code: Code QTW
Advisory panel: Ophthalmic
Date received: 2020-12-09
Decision date: 2022-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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