VIVATHERM THEMPERATURE MEASUREMENT SYSTEM

VIVATHERM THEMPERATURE MEASUREMENT SYSTEM is an FDA 510(k)-cleared medical device (K031556) manufactured by Vivant Medical, Inc.. 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 22, 2003. Regulation: 8.