SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM

SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM is an FDA 510(k)-cleared medical device (K132402) 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 February 20, 2014. Regulation: 8.