MODEL 509M PULSE OXIMETER, MODEL 509M

MODEL 509M PULSE OXIMETER, MODEL 509M is an FDA 510(k)-cleared medical device (K032755) manufactured by Respironics Novametrix, 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 May 20, 2004. Regulation: 8.