Cleared Traditional

K002985 - ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
(FDA 510(k) Clearance)

K002985 · Ics Medical Corp. · Neurology
Dec 2000
Decision
79d
Days
Class 2
Risk

K002985 is an FDA 510(k) clearance for the ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on December 13, 2000, 79 days after receiving the submission on September 25, 2000. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K002985 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2000
Decision Date December 13, 2000
Days to Decision 79 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