BRAEMAR CARDIOKEY HOLTER RECORDER

BRAEMAR CARDIOKEY HOLTER RECORDER is an FDA 510(k)-cleared medical device (K130294) manufactured by Braemar Manufacturing, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 2013. Regulation: 8.