SPAULDING IQ ELECTROCARDIOGRAPH

SPAULDING IQ ELECTROCARDIOGRAPH is an FDA 510(k)-cleared medical device (K110065) manufactured by Spaulding Clinical Research, 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 March 1, 2011. Regulation: 8.