EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER

EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER is an FDA 510(k)-cleared medical device (K881820) manufactured by Edentec Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 1988. Regulation: 8.