CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE

CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE is an FDA 510(k)-cleared medical device (K911308) manufactured by Medical Equipment Designs, 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 September 10, 1991. Regulation: 8.