AQUASONIC 100 ULTRASOUND TRANS. GEL,

AQUASONIC 100 ULTRASOUND TRANS. GEL, is an FDA 510(k)-cleared medical device (K802146) manufactured by Parker Laboratories, 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 October 9, 1980. Regulation: 8.