SLEEPSCREEN/APNOESCREEN CARDIO

SLEEPSCREEN/APNOESCREEN CARDIO is an FDA 510(k)-cleared medical device (K021138) manufactured by Erich Jaeger GmbH. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 11, 2003. Regulation: 8.