
Advanced Brain Monitoring, Inc.
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APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 is an FDA 510(k)-cleared medical device (K071230) manufactured by Advanced Brain Monitoring, 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 October 2, 2007. Regulation: 8.