PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor

PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor is an FDA 510(k)-cleared medical device (K181292) manufactured by Cogentix Medical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 2018. Regulation: 8.