TS 564/PF

TS 564/PF is an FDA 510(k)-cleared medical device (K950247) manufactured by Bressler, Amery & Ross. 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 November 16, 1995. Regulation: 8.