EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE

EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE is an FDA 510(k)-cleared medical device (K132073) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 8, 2013. Regulation: 8.