ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION

ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION is an FDA 510(k)-cleared medical device (K923335) manufactured by Advanced Medical Systems, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 1994. Regulation: 8.