PORTABLE MEDICAL ULTRASOUND SCANNER

PORTABLE MEDICAL ULTRASOUND SCANNER is an FDA 510(k)-cleared medical device (K800434) manufactured by Bion Ent., Ltd.. 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 9, 1980. Regulation: 8.