MODEL 2000 PULSE OXIMETER

MODEL 2000 PULSE OXIMETER is an FDA 510(k)-cleared medical device (K982255) manufactured by Ivy Biomedical Systems, 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 October 21, 1998. Regulation: 8.