DMS 300-2W HOLTER ECG RECORDER

DMS 300-2W HOLTER ECG RECORDER is an FDA 510(k)-cleared medical device (K133014) manufactured by Diagnostic Monitoring Software. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 2014. Regulation: 8.