OXYTRAK(TM) PULSE OXIMETER

OXYTRAK(TM) PULSE OXIMETER is an FDA 510(k)-cleared medical device (K894100) manufactured by Critikon Company, LLC. 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 8, 1990. Regulation: 8.