EPIC SPO2 FINGER SENSOR, MODEL E412-20

EPIC SPO2 FINGER SENSOR, MODEL E412-20 is an FDA 510(k)-cleared medical device (K002223) 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 August 21, 2000. Regulation: 8.