OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM

OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K944017) manufactured by Olympus America, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 1995. Regulation: 8.