DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER

DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER is an FDA 510(k)-cleared medical device (K001688) manufactured by Datex-Ohmeda, 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 June 29, 2000. Regulation: 8.