5F ELECTRODE(LITHOTRIPTOR)

5F ELECTRODE(LITHOTRIPTOR) is an FDA 510(k)-cleared medical device (K852874) manufactured by Northgate Research, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 1985. Regulation: 8.