MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION

MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION is an FDA 510(k)-cleared medical device (K991786) manufactured by General Electric Medical Systems Information Techn. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 1999. Regulation: 8.