3 CHANNEL DIGITAL AMBULATORY ECG RECORDER

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER is an FDA 510(k)-cleared medical device (K971670) manufactured by Galix Biomedical Instrumentation, 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 January 28, 1998. Regulation: 8.