INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM

INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K061640) manufactured by Integra LifeSciences Corporation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 2006. Regulation: 8.