ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085

ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 is an FDA 510(k)-cleared medical device (K122996) manufactured by Xhale. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 2013. Regulation: 8.