HEALTHDYNE APNEA/HEART MONITOR, MODEL 900

HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 is an FDA 510(k)-cleared medical device (K874695) manufactured by Healthdyne, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 28, 1988. Regulation: 8.