MODEL 8604-FO PULSE OXIMETER

MODEL 8604-FO PULSE OXIMETER is an FDA 510(k)-cleared medical device (K910001) 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 July 17, 1991. Regulation: 8.