HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300

HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 is an FDA 510(k)-cleared medical device (K911615) 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 January 7, 1992. Regulation: 8.