Cleared Traditional

ICS CHARTR EP 200 WITH VEMP

K143670 · Gn Otometrics A/S · Neurology
Oct 2015
Decision
303d
Days
Class 2
Risk

About This 510(k) Submission

K143670 is an FDA 510(k) clearance for the ICS CHARTR EP 200 WITH VEMP, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Gn Otometrics A/S (Taastrup, DK). The FDA issued a Cleared decision on October 23, 2015, 303 days after receiving the submission on December 24, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K143670 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2014
Decision Date October 23, 2015
Days to Decision 303 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