TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM

TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K020537) manufactured by Tensys Medical, 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 August 14, 2002. Regulation: 8.