Cleared Traditional

ICS CHARTR EP 200

K083399 · Gn Otometrics A/S · Neurology
Feb 2009
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K083399 is an FDA 510(k) clearance for the ICS CHARTR EP 200, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Gn Otometrics A/S (Schaumburg, US). The FDA issued a Cleared decision on February 20, 2009, 95 days after receiving the submission on November 17, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K083399 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2008
Decision Date February 20, 2009
Days to Decision 95 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