Assurance Alar / Nasal SpO2 Sensor

Assurance Alar / Nasal SpO2 Sensor is an FDA 510(k)-cleared medical device (K143216) manufactured by Xhale, 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 March 16, 2015. Regulation: 8.