MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL

MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL is an FDA 510(k)-cleared medical device (K853669) manufactured by Hewlett-Packard Co.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 30, 1986. Regulation: 8.