RETeval Visual Electrodiagnostic Device— 510(k) K142567

Name: FDA 510(k) clearance K142567
Creator: U.S. Food and Drug Administration
Published: 2015-05-19

Substantially Equivalent

Lkc Technologies, Inc.

FDA 510(k) clearance K142567 for RETeval Visual Electrodiagnostic Device, Substantially Equivalent on 2015-05-19. Applicant: Lkc Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Lkc Technologies, Inc.
Product code: Code GWE
Device class: Class 2
Regulation: 21 CFR 882.1890
Advisory panel: Neurology
Date received: 2014-09-12
Decision date: 2015-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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