C/PES 9103, ECG STRESS TESTING SYSTEM

C/PES 9103, ECG STRESS TESTING SYSTEM is an FDA 510(k)-cleared medical device (K850113) manufactured by Gould, 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 February 7, 1985. Regulation: 8.