HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME

HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME is an FDA 510(k)-cleared medical device (K111159) manufactured by Cardiocomm Solutions, 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 December 21, 2011. Regulation: 8.