ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)

ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) is an FDA 510(k)-cleared medical device (K930964) manufactured by Acuson Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 25, 1994. Regulation: 8.