LIFEWATCH(R) PORTABLE MONITORING SYSTEM

LIFEWATCH(R) PORTABLE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K864419) manufactured by Lifewatch Systems, 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 March 15, 1987. Regulation: 8.