DM-400 HOLTER ECG CASSETTE RECORDER

DM-400 HOLTER ECG CASSETTE RECORDER is an FDA 510(k)-cleared medical device (K970298) manufactured by Diagnostic Monitoring. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 19, 1997. Regulation: 8.