SUMMED INFLATION DEVICE KIT

SUMMED INFLATION DEVICE KIT is an FDA 510(k)-cleared medical device (K133795) manufactured by Sunny Medical Device (Shenzhen) 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 December 11, 2014. Regulation: 8.