ECG MONITOR MODEL DS-3130/3140

ECG MONITOR MODEL DS-3130/3140 is an FDA 510(k)-cleared medical device (K961174) 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 June 20, 1996. Regulation: 8.