SERENO ELECTRONIC STETHOSCOPE

SERENO ELECTRONIC STETHOSCOPE is an FDA 510(k)-cleared medical device (K062481) manufactured by Pishon High Tech Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 2006. Regulation: 8.