MONITOR, HEART RATE MODEL 103

MONITOR, HEART RATE MODEL 103 is an FDA 510(k)-cleared medical device (K782089) manufactured by Roche Medical Electronics, 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 January 3, 1979. Regulation: 8.