PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER

PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER is an FDA 510(k)-cleared medical device (K072538) manufactured by United Medical Systems, 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 January 29, 2008. Regulation: 8.