Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems is an FDA 510(k)-cleared medical device (K152944) manufactured by Mortara Instrument, 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 5, 2016. Regulation: 8.