Cleared Traditional

K960097 - CHARTR EP
(FDA 510(k) Clearance)

K960097 · Ics Medical Corp. · Neurology
Feb 1997
Decision
407d
Days
Class 2
Risk

K960097 is an FDA 510(k) clearance for the CHARTR EP, 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 February 21, 1997, 407 days after receiving the submission on January 11, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K960097 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1996
Decision Date February 21, 1997
Days to Decision 407 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

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