Cleared Traditional

SmartEP

K163326 · Intelligent Hearing Systems · Neurology
Sep 2017
Decision
305d
Days
Class 2
Risk

About This 510(k) Submission

K163326 is an FDA 510(k) clearance for the SmartEP, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on September 29, 2017, 305 days after receiving the submission on November 28, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K163326 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2016
Decision Date September 29, 2017
Days to Decision 305 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWJ — Stimulator, Auditory, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1900