HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S

HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S is an FDA 510(k)-cleared medical device (K892006) 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 May 22, 1989. Regulation: 8.