REDSENSE-ALARM UNIT AND SENSOR

REDSENSE-ALARM UNIT AND SENSOR is an FDA 510(k)-cleared medical device (K103242) manufactured by Redsense Medical AB. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2011. Regulation: 8.