MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER

MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER is an FDA 510(k)-cleared medical device (K844916) manufactured by Hoffrel Instruments, 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 April 21, 1985. Regulation: 8.