E100 SERIES SPO2 SENSORS

E100 SERIES SPO2 SENSORS is an FDA 510(k)-cleared medical device (K970098) 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 April 29, 1998. Regulation: 8.