HEART SYNC PEDIATRIC, MODEL PED-100

HEART SYNC PEDIATRIC, MODEL PED-100 is an FDA 510(k)-cleared medical device (K081442) manufactured by Heart Sync, 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 September 23, 2008. Regulation: 8.