SKYLINE 55, MODEL VER 1

SKYLINE 55, MODEL VER 1 is an FDA 510(k)-cleared medical device (K092153) manufactured by Larsen & Toubro Limited. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2009. Regulation: 8.