BEDSIDE MONITOR, MODEL OPV-1500

BEDSIDE MONITOR, MODEL OPV-1500 is an FDA 510(k)-cleared medical device (K032749) manufactured by Nihon Kohden America, 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 September 15, 2003. Regulation: 8.