ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS

ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS is an FDA 510(k)-cleared medical device (K920364) manufactured by Biosound, 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 March 16, 1992. Regulation: 8.