Shape-HF Cardiopulmonary Testing System

Shape-HF Cardiopulmonary Testing System is an FDA 510(k)-cleared medical device (K150888) manufactured by Shape Medical Systems, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 2016. Regulation: 8.