TELEMETRY SYSTEM XMT-1 & REC-1

TELEMETRY SYSTEM XMT-1 & REC-1 is an FDA 510(k)-cleared medical device (K792371) manufactured by Burdick Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 30, 1980. Regulation: 8.