HeartBuds Electronic Stethoscope

HeartBuds Electronic Stethoscope is an FDA 510(k)-cleared medical device (K212906) manufactured by Heartbuds, 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 13, 2023. Regulation: 8.