TRANSTHORACIC TEMP. PACEMAKER #100TPE

TRANSTHORACIC TEMP. PACEMAKER #100TPE is an FDA 510(k)-cleared medical device (K820232) manufactured by Trans Pace, 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 April 8, 1982. Regulation: 8.