BCI 3403 SLEEP SCREENING PULSE OXIMETER

BCI 3403 SLEEP SCREENING PULSE OXIMETER is an FDA 510(k)-cleared medical device (K011156) manufactured by Bci, 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 June 13, 2001. Regulation: 8.