SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS,

SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, is an FDA 510(k)-cleared medical device (K974269) manufactured by Medison 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 August 20, 1998. Regulation: 8.