Cleared Traditional

K991497 - ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
(FDA 510(k) Clearance)

K991497 · Ics Medical Corp. · Neurology
Jul 1999
Decision
90d
Days
Class 2
Risk

K991497 is an FDA 510(k) clearance for the ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on July 28, 1999, 90 days after receiving the submission on April 29, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K991497 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1999
Decision Date July 28, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWN — Nystagmograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1460