UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM

UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K081919) manufactured by Fukuda Denshi Co., Ltd.. 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 8, 2008. Regulation: 8.