BREATHGUARD APNEA MONITOR

BREATHGUARD APNEA MONITOR is an FDA 510(k)-cleared medical device (K872833) manufactured by Lada Intl., 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 March 31, 1988. Regulation: 8.