NOVAMETRIX PULSE OXIMETER, MODEL 500

NOVAMETRIX PULSE OXIMETER, MODEL 500 is an FDA 510(k)-cleared medical device (K853124) manufactured by Novametrix Medical 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 November 5, 1985. Regulation: 8.