Zynex Monitoring System, Model CM-1600

Zynex Monitoring System, Model CM-1600 is an FDA 510(k)-cleared medical device (K223217) manufactured by Zynex Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2023. Regulation: 8.