DIGITAL AMBULATORY ECG (HOLTER) RECORDER

DIGITAL AMBULATORY ECG (HOLTER) RECORDER is an FDA 510(k)-cleared medical device (K031074) manufactured by Datrix. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 2003. Regulation: 8.