
Biomedical Systems Corp.
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TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K100155) manufactured by Biomedical Systems Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 2010. Regulation: 8.