EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170

EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 is an FDA 510(k)-cleared medical device (K913749) manufactured by Edentec Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 1992. Regulation: 8.