BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720

BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 is an FDA 510(k)-cleared medical device (K981394) manufactured by Braemar 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 September 27, 1998. Regulation: 8.