PRO-SPORT HEART RATE MONITOR

PRO-SPORT HEART RATE MONITOR is an FDA 510(k)-cleared medical device (K943242) manufactured by Sensor Dynamics, 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 March 9, 1995. Regulation: 8.