ASTHMA MONITOR MODEL, AM1

ASTHMA MONITOR MODEL, AM1 is an FDA 510(k)-cleared medical device (K090486) manufactured by Cardinal Health Germany 234 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 May 5, 2009. Regulation: 8.