TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION

TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION is an FDA 510(k)-cleared medical device (K914971) 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 December 3, 1991. Regulation: 8.