ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM

ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K070710) manufactured by Biosensors International-USA. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 18, 2007. Regulation: 8.