TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM

TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM is an FDA 510(k)-cleared medical device (K952659) manufactured by Tronomed, 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 January 10, 1996. Regulation: 8.