THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES

THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES is an FDA 510(k)-cleared medical device (K033790) manufactured by Tecnimed S.R.L.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 2004. Regulation: 8.