DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM

DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM is an FDA 510(k)-cleared medical device (K944833) manufactured by New England Medical Monitoring Co.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 1995. Regulation: 8.