
Shape Medical Systems, Inc.
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SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM is an FDA 510(k)-cleared medical device (K090722) 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 March 30, 2009. Regulation: 8.