I-Portal Portable Assessment System - Nystagmograph (I-PAS)

I-Portal Portable Assessment System - Nystagmograph (I-PAS) is an FDA 510(k)-cleared medical device (K171884) manufactured by Neuro Kinetics, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 2017. Regulation: 8.