
Ivy Biomedical Systems, Inc.
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CARDIAC TRIGGER, MODEL: CTM300 is an FDA 510(k)-cleared medical device (K083854) manufactured by Ivy Biomedical Systems, 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 12, 2009. Regulation: 8.