GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300

GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 is an FDA 510(k)-cleared medical device (K921068) 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 March 29, 1992. Regulation: 8.