MODEL 8500 HAND HELD PULSE OXIMETER

MODEL 8500 HAND HELD PULSE OXIMETER is an FDA 510(k)-cleared medical device (K893221) manufactured by Nonin Medical, 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 February 27, 1990. Regulation: 8.