REUSABLE FINGER CLIP SPO2 SENSORS

REUSABLE FINGER CLIP SPO2 SENSORS is an FDA 510(k)-cleared medical device (K042704) manufactured by Elekon Industries U.S.A., 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 November 25, 2004. Regulation: 8.