Cleared Traditional

RETeval Visual Electrodiagnostic Device

K142567 · Lkc Technologies, Inc. · Neurology
May 2015
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K142567 is an FDA 510(k) clearance for the RETeval Visual Electrodiagnostic Device, a Stimulator, Photic, Evoked Response (Class II — Special Controls, product code GWE), submitted by Lkc Technologies, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on May 19, 2015, 249 days after receiving the submission on September 12, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1890.

Submission Details

510(k) Number K142567 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2014
Decision Date May 19, 2015
Days to Decision 249 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWE — Stimulator, Photic, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1890