300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER

300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER is an FDA 510(k)-cleared medical device (K874090) manufactured by Medac, 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 December 14, 1987. Regulation: 8.