SERIES 4000 STRESS & EXERCISE SYSTEM

SERIES 4000 STRESS & EXERCISE SYSTEM is an FDA 510(k)-cleared medical device (K801903) manufactured by Instruments For Cardiac Research. 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 10, 1981. Regulation: 8.