MODIFICATION TO SYSTEM 83 PLUS

MODIFICATION TO SYSTEM 83 PLUS is an FDA 510(k)-cleared medical device (K983017) manufactured by Custom Ultrasonics. 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 September 21, 1998. Regulation: 8.