ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM

ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM is an FDA 510(k)-cleared medical device (K991497) manufactured by Ics Medical Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 1999. Regulation: 8.