FLEXI-SITE SP02 EAR SENSOR

FLEXI-SITE SP02 EAR SENSOR is an FDA 510(k)-cleared medical device (K012333) manufactured by Epic Medical Equipment Services, 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 October 16, 2001. Regulation: 8.