APPRAISE-HRI

APPRAISE-HRI is an FDA 510(k)-cleared medical device (K233249) manufactured by The Surgeon General, Department of the Army (TSG-DA). This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 4, 2024. Regulation: 8.