ECG MONITOR AND RESPIRATION PACER

ECG MONITOR AND RESPIRATION PACER is an FDA 510(k)-cleared medical device (K881055) manufactured by D. E. Hokanson, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 18, 1988. Regulation: 8.