TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE

TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE is an FDA 510(k)-cleared medical device (K854013) manufactured by Medrand, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 27, 1986. Regulation: 8.