PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)

PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) is an FDA 510(k)-cleared medical device (K983196) manufactured by Tz Medical, 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 14, 1999. Regulation: 8.