PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH

PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH is an FDA 510(k)-cleared medical device (K902368) manufactured by Esaote Biomedica Spa. 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 10, 1990. Regulation: 8.