MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR

MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR is an FDA 510(k)-cleared medical device (K961972) manufactured by Aequitron Medical, 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 April 17, 1997. Regulation: 8.