ELECTRODE, MODEL 030-324/4 GUAGE

ELECTRODE, MODEL 030-324/4 GUAGE is an FDA 510(k)-cleared medical device (K781824) manufactured by Telectronics, 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 February 7, 1979. Regulation: 8.