OLYMPUS CRITICAL CARE MONITORING SYSTEM

OLYMPUS CRITICAL CARE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K963935) manufactured by Optical Sensors, 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 January 22, 1997. Regulation: 8.