Nihon Kohden NKV-440 Ventilator System

Nihon Kohden NKV-440 Ventilator System is an FDA 510(k)-cleared medical device (K222644) manufactured by Nihon Kohden Orangemed, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 30, 2023. Regulation: 8.