TRANSONIC HCM 103 SYSTEM

TRANSONIC HCM 103 SYSTEM is an FDA 510(k)-cleared medical device (K134035) manufactured by Transonic 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 September 16, 2014. Regulation: 8.