REFLECTANCE SENSOR (RS-10)

REFLECTANCE SENSOR (RS-10) is an FDA 510(k)-cleared medical device (K904039) manufactured by Nellcor, 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 December 26, 1990. Regulation: 8.