SENSIS, SENSIS LITE

SENSIS, SENSIS LITE is an FDA 510(k)-cleared medical device (K131812) manufactured by Siemens Medi Cal Solutions, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 24, 2013. Regulation: 8.