SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000

SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 is an FDA 510(k)-cleared medical device (K003458) manufactured by Clinical Innovations, 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 May 2, 2001. Regulation: 8.