INFANT APNEA MONITOR MODEL 100

INFANT APNEA MONITOR MODEL 100 is an FDA 510(k)-cleared medical device (K812045) manufactured by Medix Medical Electronics (U.S.A.), Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 23, 1981. Regulation: 8.