FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01

FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 is an FDA 510(k)-cleared medical device (K862072) manufactured by International Biomedics, 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 8, 1986. Regulation: 8.