MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR

MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR is an FDA 510(k)-cleared medical device (K133753) manufactured by Infobionic, 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 18, 2014. Regulation: 8.