ACUDATA INDICATENS MODEL 5A

ACUDATA INDICATENS MODEL 5A is an FDA 510(k)-cleared medical device (K900596) manufactured by Acudata Software. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 1990. Regulation: 8.