OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM

OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K900881) manufactured by Codman & Shurtleff, 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 September 24, 1990. Regulation: 8.