DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM

DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K892370) manufactured by Bio-Focus, 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 August 27, 1989. Regulation: 8.