3420 DIGIT PULSE OXIMETER, MODEL 3420

3420 DIGIT PULSE OXIMETER, MODEL 3420 is an FDA 510(k)-cleared medical device (K013171) 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 January 2, 2002. Regulation: 8.