Apnea Risk Evaluation System (ARES), Model 620

Apnea Risk Evaluation System (ARES), Model 620 is an FDA 510(k)-cleared medical device (K160499) manufactured by Watermark Medical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 23, 2017. Regulation: 8.