TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM

TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K121141) manufactured by Tensys Medical Systems, 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 May 14, 2012. Regulation: 8.