ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410

ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410 is an FDA 510(k)-cleared medical device (K853755) manufactured by Victoreen, 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 November 25, 1985. Regulation: 8.