ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000

ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000 is an FDA 510(k)-cleared medical device (K933645) manufactured by Hitachi Medical Systems America, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 1993. Regulation: 8.