FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1

FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 is an FDA 510(k)-cleared medical device (K023723) manufactured by Fms, Finapres Medical Systems BV. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 22, 2003. Regulation: 8.