ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS

ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS is an FDA 510(k)-cleared medical device (K860081) manufactured by Elscint, 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 15, 1986. Regulation: 8.