CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION is an FDA 510(k)-cleared medical device (K093288) manufactured by Cardionet, 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 April 7, 2010. Regulation: 8.